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The Effects of a Stainless Steel Suture MGH Flexor Tendon Repair Coupled With Early Aggressive Range of Motion Rehabilitation: a Randomized Controlled Trial

NCT01344980 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-04-29

No results posted yet for this study

Summary

The investigators are comparing the combination of a stainless steel repair and aggressive early active range of motion rehabilitation protocol for flexor tendon lacerations in the hand with a current, accepted treatment offered at our institution. Outcomes to be assessed will be time to return to work, joint range of motion in the injured fingers, and any potential complications that may arise (ex: surgical infections or repair rupture). All proposed treatments included in this study are currently being offered at our institution, but not in a randomized fashion.

Conditions

  • Zone 2 Flexor Tendon Lacerations of the Hand

Interventions

PROCEDURE

Stainless steel suture

Stainless steel suture material will be used (size 3-0) in an MGH repair technique

PROCEDURE

Polypropylene suture

Polypropylene suture (size 3-0) will be used in a double-locking loop repair technique

BEHAVIORAL

Aggressive early active range of motion rehabilitation

Patients undergoing this form of rehabilitation will have their splints discontinued at 4 weeks and ideally will be back at work at normal duties by 6 weeks. This rehabilitation uses more movement at a faster progression than other early active range of motion protocols.

BEHAVIORAL

Early active range of motion rehabilitation

Patients undergoing this form of rehabilitation will have their splints discontinued at 6 weeks and ideally will be back at work at normal duties by 10-12 weeks. This rehabilitation uses less movement at a slower progression than the early AROM rehabilitation protocol specified in the experimental group

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01344980 on ClinicalTrials.gov