Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000294055
Ethics application status
Approved
Date submitted
29/03/2010
Date registered
13/04/2010
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy of two exercise protocols following fracture and open surgical fixation of the proximal phalangeal bone in the finger.
Scientific title
In adults with finger proximal phalangeal fractures, are constrained wrist-finger exercises more effective than unconstrained finger tendon gliding exercises in improving range of motion and grip strength following open reduction and internal fixation (ORIF)
Secondary ID [1] 1592 0
Nil
Universal Trial Number (UTN)
U1111-1114-5256
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open reduction and internal fixation (ORIF) following finger proximal phalanx fracture. 257037 0
Condition category
Condition code
Injuries and Accidents 257194 257194 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A will undertake a novel combination of synergistic wrist-finger exercises within the constraints of a removable splint after ORIF of proximal phalangeal fracture of the finger.
The frequency of these exercises will be 10 completions of the exercise sequence, repeated a minimum of 6 times throughout the waking day.
The duration of the exercise program is 6 weeks.
The mode of administration will be that exercises are taught one-on-one with a Hand Physiotherapist or Occupational Therapist initially, and then practiced on an individual basis unsupervised until the next review appointment, where the program will be checked and reiterated. This will be repeated weekly for 6 weeks.
Intervention code [1] 256209 0
Rehabilitation
Intervention code [2] 256211 0
Treatment: Other
Comparator / control treatment
Group B will perform traditional unconstrained finger tendon gliding exercises after ORIF of proximal phalangeal fracture of the finger.
The frequency of these exercises will be 10 completions of the exercise sequence, repeated a minimum of 6 times throughout the waking day.
The duration of the exercise program is 6 weeks.
The mode of administration will be that exercises are taught one-on-one with a Hand Physiotherapist or Occupational Therapist initially, and then practiced on an individual basis unsupervised until the next review appointment, where the program will be checked and reiterated. This will be repeated weekly for 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 258088 0
Active extension at the proximal interphalangeal (PIP) joint of the injured finger measured using a finger goniometer.
Timepoint [1] 258088 0
Enrolment visit; 6 weeks; and 12 weeks after surgery
Primary outcome [2] 258095 0
Total active range of motion of the injured finger measured using a finger goniometer.
Timepoint [2] 258095 0
Enrolment visit; 6 weeks; and 12 weeks
Primary outcome [3] 258096 0
Grip strength measured using the hand held Jamar Dynamometer.
Timepoint [3] 258096 0
6 weeks; and 12 weeks after surgery
Secondary outcome [1] 263694 0
Activity limitation and participation levels will be measured via the Patient Rated Wrist and Hand Evaluation (PRWHE) questionnaire.
Timepoint [1] 263694 0
12 weeks after surgery

Eligibility
Key inclusion criteria
All adults (age range: 18- 65 years of age) with finger proximal phalangeal fractures that were stabilised via open reduction internal fixation (with plate and screw fixation or screw fixation alone) at Sydney Hospital Hand Unit are candidates for inclusion in the study. Participants must also have a willingness to give written informed consent and willingness to participate in and comply with the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) there was a delay between fracture and surgical fixation greater than two weeks,
(2) the surgical procedure did not achieve stability,
(3) there is the presence of co- morbidities including diabetes and active arthropathy,
(4) there is concomitant tendon or nerve injury, other fracture or vascular injury,
(5) there are cognition problems or poor pain awareness,
(6) there is an inability to attend regular hand therapy follow- up appointments.
(7) patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Upon return to the hand clinic at Sydney Hospital for their initial post- operative review following open reduction internal fixation of their finger proximal phalanx fracture, all potential participants will be approached by an independent member of the Hand Clinic team who will not be involved in their treatment or in the study. The project will be explained and the option to participate will be offered. Should they agree, signed consent will be collected at this stage and initial baseline measures will be undertaken prior to stratified randomisation. The researcher will not be involved in the recruitment process.
The participant will be enrolled into the study after the informed consent process has been completed and the participant has met all inclusion criteria and none of the exclusion criteria. The participant will receive a study enrolment number and this will be documented in the participant’s medical record and on all study documents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participant will be randomised (via stratified randomisation) at initial study visit after they have met the enrolment criteria. At this visit the participant will be randomised to study procedure A (Constrained wrist- finger exercises) or Study procedure B (Unconstrained tendon gliding exercises), and receive a Randomisation Number allocated by Hand Clinic. This number will be from a computer generated sequence.
As standard randomisation alone has the potential to create imbalances on baseline characteristics of treatment groups (Altman et al, 2001), we are electing to use prerandomisation stratification to avert the risk of such imbalances. We intend to use blocking as our form of restriction. We will use this blocking to generate separate randomisation schedules for stratified subsets of participants defined by the severity of injury. Severity of injury is an important prognostic factor following proximal phalanx fracture, and is reflected in the type of fixation required to achieve adequate stability.
Potential participants will be stratified as either a level 1 or level 2 severity. Level 1 severity are those that required plate and screws via a dorsal extensor tendon splitting approach. This is usually because the fracture was significantly displaced or occured within a joint (i.e. more severe injury). Level 2 severity are those that require less bulky fixation via screws alone through a less invasive lateral approach or fixation of fractures not within a joint (i.e. less severe injury). This is usually possible because the fracture is not hugely displaced or lies within the shaft of the bone.

We hope stratified randomisation will be particularly helpful to avert severe imbalances on prognostive factors in this case due to our trial being small, and may improve statistical power and precision (Meinert, 1986).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
20/05/2010
Date of last participant enrolment
Anticipated
Actual
10/12/2013
Date of last data collection
Anticipated
Actual
10/06/2014
Sample size
Target
66
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 256710 0
Self funded/Unfunded
Name [1] 256710 0
Country [1] 256710 0
Australia
Primary sponsor type
Individual
Name
A/Prof Jack Crosbie
Address
Faculty of Health Sciences
Cumberland Campus C.42
The University of Sydney
East Street
Lidcombe NSW
2141
Country
Australia
Secondary sponsor category [1] 255997 0
Individual
Name [1] 255997 0
Lauren Miller
Address [1] 255997 0
c/o The Hand Therapy Department
Sydney/ Sydney Eye Hospital
8 Macquarie St
Sydney NSW
2000
Country [1] 255997 0
Australia
Secondary sponsor category [2] 255998 0
Individual
Name [2] 255998 0
Dr Anne Wajon
Address [2] 255998 0
3 Figtree Road
Hunters Hill NSW
2110
Country [2] 255998 0
Australia
Other collaborator category [1] 280213 0
Individual
Name [1] 280213 0
Professor Louise Ada
Address [1] 280213 0
Faculty of Health Sciences Cumberland Campus C.42 The University of Sydney East Street Lidcombe NSW 2141
Country [1] 280213 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258725 0
Northern Hospitals Network (NHN) South Eastern Sydney and Illawarra Area Health Service (SESIAHS) Human Research Ethics Committee (HREC)
Ethics committee address [1] 258725 0
Ethics committee country [1] 258725 0
Australia
Date submitted for ethics approval [1] 258725 0
Approval date [1] 258725 0
04/03/2010
Ethics approval number [1] 258725 0
1/09/0169

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30982 0
Ms Lauren Miller
Address 30982 0
c/o The Hand Therapy Department Sydney/ Sydney Eye Hospital 8 Macquarie Street Sydney 2000 NSW
Country 30982 0
Australia
Phone 30982 0
+61 2 93827201
Fax 30982 0
Email 30982 0
[email protected]
Contact person for public queries
Name 14229 0
Lauren Miller
Address 14229 0
c/o The Hand Therapy Department
Sydney/ Sydney Eye Hospital
8 Macquarie Street
Sydney 2000
NSW
Country 14229 0
Australia
Phone 14229 0
+61 2 93827201
Fax 14229 0
Email 14229 0
[email protected]
Contact person for scientific queries
Name 5157 0
Jack Crosbie
Address 5157 0
Faculty of Health Sciences
Cumberland Campus C.42
The University of Sydney
East Street,
Lidcombe NSW 2141
Country 5157 0
Australia
Phone 5157 0
+61 2 93519180
Fax 5157 0
Email 5157 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNo difference between two types of exercise after proximal phalangeal fracture fixation: a randomised trial.2016https://dx.doi.org/10.1016/j.jphys.2015.11.006
N.B. These documents automatically identified may not have been verified by the study sponsor.