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

A Pilot Study of a Randomized Controlled Trial Comparing Stainless Steel Suture Repair Coupled With Aggressive Post-Operative Rehabilitation to Polypropylene Suture Paired With Active Range of Motion Rehabilitation

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.

Study Overview

• Status: Unknown
• Conditions: Zone 2 Flexor Tendon Lacerations of the Hand
• Intervention / Treatment: Procedure: Stainless steel suture; Behavioral: Aggressive early active range of motion rehabilitation; Procedure: Polypropylene suture; Behavioral: Early active range of motion rehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Leif J Sigurdson, MD; Phone Number: 204-787-7374; Email: lsigurdson2@exchange.hsc.mb.ca
• Study Contact Backup: Name: Ian R MacArthur, MD; Phone Number: 204-990-6397; Email: i_macarthur@shaw.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Center
      • Contact: Leif J Sigurdson, MD; Phone Number: 204-787-7374; Email: Leif Sigurdson <lsigurdson2@exchange.hsc.mb.ca>
      • Principal Investigator: Ian R MacArthur, MD
      • Sub-Investigator: Sarvesh Logsetty, MD
      • Sub-Investigator: Leif J Sigurdson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Stainless steel suture; Stainless steel suture material will be used (size 3-0) in an MGH 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.
Active Comparator: 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.	Procedure: Polypropylene suture; Polypropylene suture (size 3-0) will be used in a double-locking loop repair technique; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to work	At each clinic visit at the above mentioned time periods, the clinician will ask the patient if they have returned to work (if applicable)	Post-operative weeks 1, 2, 4, 6 and 12
Finger joint range of motion (PIP, DIP, MCP)	At each clinic / occupational therapy visit, a blinded assessor will determine the total range of motion of the finger DIP, PIP and MCP joints	Post-operative weeks 1, 2, 4, 6 and 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with therapy	At each clinic and occupational therapy visit, an assessor will ask the patient if they have been compliant with therapy	Post-operative weeks 1, 2, 4, 6 and 12
Rupture	At each follow-up visit with the clinician or occupational therapist, the presence of a rupture will be assessed for clinically. Alternatively this will be recorded if the patient presents to the emergency room with a flexor tendon rupture	Post-operative weeks 1, 2, 4, 6 and 12
Infection	At each clinic visit, the patient will be assessed clinically for the presence or absence of an infection. This will also be noted if the patient presents to the emergency room.	Post-operative weeks 1, 2, 4, 6 and 12
Attendance with follow-up clinic and occupational therapy	The patient's attendance will be determined at each clinic or occupational therapy visit.	Post-operative weeks 1, 2, 4, 6 and 12
Use of oral analgesics	At each clinic visit, the patient will be asked if they are still using oral analgesics	Post-operative weeks 1, 2, 4, 6 and 12
Oral antibiotic usage	At each clinic visit, the patient will be asked if they are using oral antibiotics.	Post-operative weeks 1, 2, 4, 6 and 12
Wound dehiscence (breakdown)	At each clinic and occupational therapy visit, the patient will be assessed to determine if a wound dehiscence (breakdown) has occurred.	Post-operative weeks 1, 2, 4, 6 and 12
Use of occupational therapy adjunctive treatments	At each occupational therapy visit, it will be recorded that they are either using or not using occupational therapy adjunctive treatments (ex: coban tape, ultrasound or electrical stimulation)	Post-operative weeks 1, 2, 4, 6 and 12

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): April 29, 2011
• Last Update Submitted That Met QC Criteria: April 28, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: B2010:119