Early Functional Return to Work Following Distal Biceps Repair

NCT02505347 | Completed

• 1 other identifier: Pro00057067
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biceps Tendon Rupture

Outcome Measures

Primary Outcomes (1)

• Time (days) to return to work on modified duties

  Self reported

  1 year

Secondary Outcomes (2)

• Time (days) to return to pre-injury level of work

  12 months

• Re-rupture rate

  12 months

Other Outcomes (4)

• Range of Motion

  Baseline, 6 weeks, 3 months, 6 months, 12 months

• Elbow strength (flexion, supination)

  baseline, 6 weeks, 3 months, 6 months, 12 months

• Quick - DASH

  baseline, 6 weeks, 3 months, 6 months, 12 months

Study Arms (2)

No splint

EXPERIMENTAL

will be able to move the arm as tolerated following surgery.

Other: No splint

Splint

ACTIVE COMPARATOR

will receive a splint following surgery for 6 weeks.

Device: Splint

Interventions

No splint OTHER

Can move arm as tolerated with no restrictions on mobility

No splint

Splint DEVICE

Wear splint for 6 weeks, only to remove for rehab and personal care

Splint

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male subjects between 18 and 65 years of age
• patient has had a DBTR amenable to surgical repair
• surgeon must be able to obtain a tension-free repair using an endobutton.
• participants must have been working prior to the injury
• patient must be expected to return to work post-injury

You may not qualify if:

• females
• outside of the specified age range
• patient with an identified congenital abnormality at the insertion of the distal biceps tendon
• those who have previously ruptured the tendon or those with tendon ruptures resulting from a multi-trauma
• patients with psychiatric illness, cognitive impairment, or health conditions that preclude informed consent
• patients with life expectancy of less than 2 years
• patients who do not speak/read/understand English
• patients with no fixed address or contact information
• patients who are unwilling to complete follow-ups

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

Location

Related Publications (1)

• Bergman JW, Silveira A, Chan R, Lapner M, Hildebrand KA, Le ILD, Sheps DM, Beaupre LA, Lalani A. Is Immobilization Necessary for Early Return to Work Following Distal Biceps Repair Using a Cortical Button Technique?: A Randomized Controlled Trial. J Bone Joint Surg Am. 2021 Oct 6;103(19):1763-1771. doi: 10.2106/JBJS.20.02047.

  PMID: 34166263 BACKGROUND

Related Links

• Study Video Summary
• OrthoEvidence

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Lauren Beaupre, PT, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 22, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 22, 2022

Record last verified: 2021-09

Locations

CA (1)