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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01066936
Registration number
NCT01066936
Ethics application status
Date submitted
9/02/2010
Date registered
10/02/2010
Date last updated
6/03/2020
Titles & IDs
Public title
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
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Scientific title
Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"
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Secondary ID [1]
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2090SMFH131
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Universal Trial Number (UTN)
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Trial acronym
MISDexa
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Hip
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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DEXA Analysis of BMD at Preoperative Visit
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Assessment method [1]
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DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
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Timepoint [1]
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Preoperative
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Primary outcome [2]
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DEXA Analysis of BMD at 3 Months
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Assessment method [2]
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DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
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Timepoint [2]
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3 Months
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Primary outcome [3]
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DEXA Analysis of BMD at 6 Months
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Assessment method [3]
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DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
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Timepoint [3]
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6 Months
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Primary outcome [4]
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DEXA Analysis of BMD at 1 Year
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Assessment method [4]
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DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
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Timepoint [4]
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1 Year
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Primary outcome [5]
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DEXA Analysis of BMD at 2 Years
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Assessment method [5]
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DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
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Timepoint [5]
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2 Year
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Secondary outcome [1]
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Baseline Harris Hip Score (HHS) at Preoperative Visit
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Assessment method [1]
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The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:
Total Scale Ranges:
Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60
Subscore Ranges:
Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5
The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
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Timepoint [1]
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Preoperative
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Secondary outcome [2]
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Harris Hip Score (HHS) at 3 Month Visit
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Assessment method [2]
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The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:
Total Scale Ranges:
Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60
Subscore Ranges:
Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5
The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
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Timepoint [2]
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3 Month
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Secondary outcome [3]
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Harris Hip Score (HHS) at 6 Month Visit
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Assessment method [3]
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The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:
Total Scale Ranges:
Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60
Subscore Ranges:
Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5
The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
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Timepoint [3]
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6 Months
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Secondary outcome [4]
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Harris Hip Score (HHS) at 1 Year Visit
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Assessment method [4]
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The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:
Total Scale Ranges:
Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60
Subscore Ranges:
Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5
The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
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Timepoint [4]
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1 Year
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Secondary outcome [5]
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Harris Hip Score (HHS) at 2 Year Visit
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Assessment method [5]
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The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:
Total Scale Ranges:
Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60
Subscore Ranges:
Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5
The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
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Timepoint [5]
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2 Years
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Secondary outcome [6]
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Harris Hip Score (HHS) at 5 Year Visit
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Assessment method [6]
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The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale:
Total Scale Ranges:
Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: \<60
Subscore Ranges:
Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5
The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
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Timepoint [6]
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5 Year
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Secondary outcome [7]
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Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
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Assessment method [7]
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The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).
Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.
Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
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Timepoint [7]
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Preoperative
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Secondary outcome [8]
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Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
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Assessment method [8]
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The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).
Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.
Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
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Timepoint [8]
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3 Months
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Secondary outcome [9]
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Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
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Assessment method [9]
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The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).
Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.
Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
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Timepoint [9]
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6 Months
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Secondary outcome [10]
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Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
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Assessment method [10]
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0
The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).
Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.
Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
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Timepoint [10]
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1 Year
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Secondary outcome [11]
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Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
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Assessment method [11]
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The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).
Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.
Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
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Timepoint [11]
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2 Years
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Secondary outcome [12]
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Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
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Assessment method [12]
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The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL).
Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points.
Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
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Timepoint [12]
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5 Years
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Secondary outcome [13]
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Radiographic Assessment at Preoperative Visit (Yes/No Components)
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Assessment method [13]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.
The Brooker Classification was defined as:
Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip
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Timepoint [13]
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Discharge
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Secondary outcome [14]
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Radiographic Assessment at 3 Month Visit (Yes/No Components)
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Assessment method [14]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.
The Brooker Classification was defined as:
Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip
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Timepoint [14]
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3 Months
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Secondary outcome [15]
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Radiographic Assessment at 1 Year Visit (Yes/No Components)
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Assessment method [15]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.
The Brooker Classification was defined as:
Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip
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Timepoint [15]
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1 Year
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Secondary outcome [16]
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Radiographic Assessment at 5 Year Visit (Yes/No Components)
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Assessment method [16]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding.
The Brooker Classification was defined as:
Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to \<1 cm Class 4 - apparent bone ankyloses of the hip
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Timepoint [16]
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5 Year
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Secondary outcome [17]
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Radiographic Assessment at Discharge Visit
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Assessment method [17]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
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Timepoint [17]
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Discharge
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Secondary outcome [18]
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Radiographic Assessment at 3 Month Visit
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Assessment method [18]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
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Timepoint [18]
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3 Months
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Secondary outcome [19]
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Radiographic Assessment at 1 Year Visit
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Assessment method [19]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
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Timepoint [19]
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1 Year
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Secondary outcome [20]
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Radiographic Assessment at 5 Year Visit
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Assessment method [20]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
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Timepoint [20]
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5 Year
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Secondary outcome [21]
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Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
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Assessment method [21]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
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Timepoint [21]
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Discharge
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Secondary outcome [22]
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Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
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Assessment method [22]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
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Timepoint [22]
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3 Months
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Secondary outcome [23]
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Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
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Assessment method [23]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
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Timepoint [23]
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1 Year
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Secondary outcome [24]
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Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
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Assessment method [24]
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Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
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Timepoint [24]
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5 Years
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Eligibility
Key inclusion criteria
* Patient has hip disease that requires a total hip arthroplasty.
* Patient is willing to consent to participate in the study.
* Patient plans to be available for the study duration.
* Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patient known to have insufficient bone stock.
* Patient has had major non-arthroscopic surgery to the study hip.
* Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
* Patient has a known sensitivity to materials in the device.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/09/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/04/2016
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Malabar Orthopaedic Clinic - Windsor
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Recruitment postcode(s) [1]
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3181 - Windsor
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Smith & Nephew, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.
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Trial website
https://clinicaltrials.gov/study/NCT01066936
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Steve McMahon, MD
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Address
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Malabar Orthopaedic Clinic
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
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0
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Address
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0
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01066936
Download to PDF