Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02505347 |
| Other study ID # |
Pro00057067 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2015 |
| Est. completion date |
September 2019 |
Study information
| Verified date |
September 2021 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Distal biceps ruptures occur most commonly among young males in their third and fourth decade
of life. These injuries are becoming more common, however, as the aging population is
remaining active through sport or labour demands. Distal biceps tears or ruptures follow a
heavy eccentric load being placed on a shortened or flexed muscle, and often require surgical
repair. Functionally, distal biceps injuries cause impairment as this portion of the muscle
is largely responsible for supination and flexion at the elbow. Currently there is no
consensus regarding post-operative immobilization protocols, and little evidence is available
regarding timeframe for early return to functional activities. Existing evidence on
functional outcomes post distal biceps tendon repair (DBTR) is of low quality with small
sample sizes, and no known RCTs exist comparing early mobilization to immobilization on
functional return. Reported timeframes for immobilization range from early controlled motion
on day 1 post-operatively to complete immobilization for 6 weeks.
The primary study goal is to determine the effect of immobilization compared to unrestricted
mobility post DBTR on early functional return to activities. It has been previously reported
that those with DBTR related to a workers compensation injury returned to full duties in 3.95
months, while those with a non-workers compensation related injury returned to full work
duties in 1.35 months. In Alberta, near 100 WCB claims were made for DBTR in both 2013 and
2014. Early mobilization of these repairs may allow an earlier return to modified and full
work duties, thereby improving the functional quality of life of the individual as well as
reducing the overall cost of disability payments.
This study will assess the 1) time to return to pre-injury work level and 2) time to return
to modified duties among those who have no movement restriction post-repair and those who are
splinted for 6 weeks. Re-rupture rates between groups will also be assessed as will strength,
range of motion (ROM) and quality of life. These findings will assist in developing a
standardized protocol for immobilization to optimize functional and clinical outcomes while
expediting return to work.
Description:
Research Questions:
In patients who are immobilized for 6 weeks and those who are allowed unrestricted movement
following DBTR, Are there differences during the first post-operative year in:
1. Time to return to work (modified and pre-injury levels)?
2. The proportion of subjects (if any) who re-rupture
a. Strength (flexion, supination) of the elbow b. ROM (flexion, supination) of the elbow c.
Self-reported functional quality of life d. Pain between groups
Research Hypotheses:
1. A shorter time to return to work (modified and pre-injury levels) will be identified for
the unrestricted movement group compared to the immobilized group.
2. Less than 2% of patients in either group will re-rupture during the first post-operative
year.
3. Patients in the unrestricted movement group will have greater early improvements in a)
strength; b) ROM; c) functional quality of life scores; and d) pain in the first 3-6
postoperative months compared to those in the immobilized group.
Theoretical significance and practical importance Currently there is no consensus regarding
post-operative immobilization protocols, and little evidence is available regarding timeframe
for early return to functional activities following DBTR. Existing evidence on functional
outcomes post DBTR is of low quality with small sample sizes, and no known RCTs exist
comparing early mobilization to immobilization on functional return. Reported timeframes for
immobilization range from early controlled motion on day 1 post-operatively to complete
immobilization for 6 weeks.
The primary study goal is to determine the effect of immobilization for 6 weeks
post-operatively compared to unrestricted mobility post DBTR on early functional return to
activities. It has been previously reported that those with DBTR related to a workers
compensation injury returned to full duties in 3.95 months, while those with a non-workers
compensation related injury returned to full work duties in 1.35 months. In Alberta, near 100
WCB claims were made annually for DBTR in both 2013 and 2014. Early mobilization of these
repairs may allow an earlier return to modified and full work duties, thereby improving the
functional quality of life of the individual as well as reducing the overall cost of
disability payments.
Research plan and methodology Design/Setting: This study is a parallel randomized control
trial with computer generated randomization blocks stratified by surgeon. Patient enrollment
and follow-up will occur primarily at Sturgeon Community Hospital (SCH).
Sample Size To ensure that the study is properly powered to detect a difference between
groups with a power = 0.90, α = 0.05, µ1 = 14 (unrestricted mobility), µ2 = 21 (immobilized),
δ = 10, a total of 88 participants is required (44 to each group). To allow for attrition of
sample size in the first year, we will enroll up to 100 subjects (50 in each study arm).
This calculation is based on a conservative estimate of a 1 week difference in return to work
between groups. If the group differences is greater than 1 week we will remain well-powered.
If the group difference is less than 1 week, this is likely not a clinically important
difference between groups.
This sample size of 100 should also be sufficient to allow for further sub-analyses between
participants who are WCB claimants and those who are not and is adequately powered to compare
the secondary and tertiary outcomes between groups, with the exception of re-ruptures, which
is expected to be very low in both groups.
Screening and Enrollment Patients will be screened for study eligibility at their initial
preoperative clinic visit by the attending surgeon and research coordinator. The research
coordinator will track reasons for exclusion, either by patient refusal or surgeon exclusion
based on patient characteristics. Those who consent will sign and complete an informed
consent form and undergo a baseline evaluation.
Baseline Evaluation: Consented subjects will undergo a pre-operative assessment by a study
therapist who is independent of their clinical care. The assessment will consist of 1)
baseline demographics form (age, mechanism of injury, past and current medical status, work
and activity demands; dominant hand), 2) work-related questions (i.e. occupation, employment
status, type of work performed) 3) the Quick Disabilities of the Arm, Shoulder, and Hand
questionnaire (Q-DASH), 4) visual analogue scale (VAS) for pain at rest and with activity 5)
bilateral elbow ROM in the planes of supination and flexion, 6) bilateral elbow strength for
flexion and supination using a handheld dynamometer (microFET3, Hoggan Health Industries
Inc., West Jordan, UT), and 7) an ultrasound or MRI to confirm the diagnosis. Imaging at this
pre-operative stage is standard of care, and not dependent on study involvement. All data
will be collected using standardized forms and entered into a password-protected database.
Intervention
Based upon the surgeons' ability to perform a tension free repair, subjects will be
randomized following surgery to either:
1. immobilized for 6 weeks postoperative or
2. unrestricted mobility Those in the immobilized group will be splinted as per current
care for 6 weeks, and will remove the splint only for personal care or active-assisted
ROM and gentle stretching exercises, as prescribed by an occupational/physical
therapist.
Those with unrestricted mobility will be able to move the joint as tolerated
post-operatively, but will avoid heavy lifting (>5 pounds) in the first six postoperative
weeks.
Those patients who consent, but are excluded at time of surgery will be noted to determine
the proportion of patients who are able to participate in an early mobilization regimen.
Reasons for exclusion will be recorded.
Rehabilitation Each patient will be referred for a course of physiotherapy post-operatively.
Although principles of tissue healing will be followed for both groups, patients in the
unrestricted mobility group are likely to start progressive resisted activities by 6-8 weeks
post-operatively while the immobilized group will likely not start progressive resisted
activities until 8-10 weeks post-operatively. Time (days) of splinting in the immobilized
group will be recorded as the time from when the splint was applied post-operatively to the
date the splint was fully discontinued. Start and end dates for physiotherapy will be
recorded as will the timing of commencing resisted activities.
Follow-up Evaluation Participants will be reassessed by the research coordinator and surgeon
at their usual clinic follow-ups at 6 weeks, and 3 and 6 months. Participants will be
reassessed by the research coordinator only at 12 months post-operatively.
At each visit outcomes to be recorded will include: current working status (not yet working,
modified, full duties) and date of return to any work, ROM measurements, Q-DASH
questionnaire, and VAS pain scale. Any complications related to their injury or causing a
delay in return to work will also be noted.
Commencing at the 3 month visit and continuing for all subsequent visits, strength will also
be assessed using a myometer. Start and end dates of physiotherapy treatment will be recorded
to compare the rehabilitation course between groups. Ultrasound imaging will be performed at
12 months, or if there is any history of re-injury to confirm the integrity of the repair.
Analysis We will be using quantitative analytical methods. Descriptive statistics
(frequencies, proportions, means and variation) will be determined for all variables.
For the primary outcome (time [days] for return to modified duties) we will use an unpaired
t-test to assess for differences between both groups. T-tests will also be used to analyze
secondary outcomes (time to return to pre-injury level of work, re-rupture rates, and Q-DASH
scores), and time (days) of splinting in the immobilized group will be reported descriptively
(mean). Tertiary outcomes (strength, ROM, Q-DASH) will be analyzed using a two-way repeated
measure ANOVA to examine the trajectory of recovery between groups.
A further sub-analysis will be performed to assess primary and secondary outcomes between
immobilized and unrestricted mobility groups for those who are identified as work related
injury compared to non-work related injury using an analysis of covariance (ANCOVA).
All analyses will be two-tailed with a level of significance of α=0.05.
