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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

NCT ID: NCT01344980

Last Updated: 2011-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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This study will serve as a pilot-study for a future randomized controlled trial. Adult patients with zone 2 flexor tendon lacerations of the hand (anatomically from the A1 pulley of the hand to the insertion of the flexor digitorum superficialis) who have presented to the emergency room acutely (within 1 week of injury) at the Health Sciences Center in Winnipeg will be asked for their participation in this study. Consent will be obtained by a plastic surgery resident either in the emergency room or in the plastic surgency emergency decanting clinic. The investigators will include twenty-four patients in the study, randomized into one of two treatment groups (groups A and B) by block randomization. Randomization will be done once patients agree to participate in the study. All patients will be booked for surgery on the emergency slate. Each treatment group will be treated by a single surgeon who is an expert at treatment of these injuries. Group A patients will have their laceration(s) repaired using a modified Becker repair technique using stainless steel suture in the operating room, and then will proceed to undergo an aggressive early active range of motion rehabilitation administered by the hand therapists at HSC. Group B patients will undergo a double-locking loop suture repair using polypropylene. They will then undergo a less aggressive active range of motion rehabilitation protocol which is currently offered to patients at our center. Follow-up will occur in plastic surgery outpatient clinic at post-operative weeks 1, 2, 4, 6 and 12. Follow-up with hand therapy will be at the discretion of the therapists. At each visit with hand therapy, joint range of motion will be assessed at the PIP and DIP joints in the affected fingers. Final range of motion will be assessed using the Strickland system for evaluating flexor tendon surgery outcomes, and will be done by a blinded hand therapist.

Conditions

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Zone 2 Flexor Tendon Lacerations of the Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Stainless steel MGH

Patients in this study arm will have their flexor tendon laceration repaired using stainless steel suture (size 3-0) in an MGH repair technique. They will then undergo aggressive early active range of motion rehabilitation post-operatively.

Group Type EXPERIMENTAL

Stainless steel suture

Intervention Type PROCEDURE

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

Aggressive early active range of motion rehabilitation

Intervention Type BEHAVIORAL

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.

Polypropylene DOLL

Patients in this study arm will have their flexor tendon laceration repaired using polypropylene suture (size 3-0) in a double-locking loop repair technique. They will then undergo aggressive early active range of motion rehabilitation post-operatively.

Group Type ACTIVE_COMPARATOR

Polypropylene suture

Intervention Type PROCEDURE

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

Early active range of motion rehabilitation

Intervention Type BEHAVIORAL

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

Interventions

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Stainless steel suture

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

Intervention Type PROCEDURE

Polypropylene suture

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

Intervention Type PROCEDURE

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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* adults
* living in Winnipeg, Manitoba
* zone II flexor tendon lacerations in a single finger
* able to consent to and comply with surgery

Exclusion Criteria

* crush injuries
* vascular injuries requiring re-vascularization
* fractures
* infection
* prior hand injury requiring surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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University of Manitoba: Department of Surgery: Section of Plastic Surgery

Locations

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Health Sciences Center

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Central Contacts

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Leif J Sigurdson, MD

Role: CONTACT

Phone: 204-787-7374

Email: [email protected]

Ian R MacArthur, MD

Role: CONTACT

Phone: 204-990-6397

Email: [email protected]

Facility Contacts

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Leif J Sigurdson, MD

Role: primary

Other Identifiers

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B2010:119

Identifier Type: -

Identifier Source: org_study_id