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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Manitoba.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01344980
First received: April 28, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Zone 2 Flexor Tendon Lacerations of the Hand
Procedure: Stainless steel suture
Procedure: Polypropylene suture
Behavioral: Aggressive early active range of motion rehabilitation
Behavioral: Early active range of motion rehabilitation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Return to work [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    At each clinic visit at the above mentioned time periods, the clinician will ask the patient if they have returned to work (if applicable)

  • Finger joint range of motion (PIP, DIP, MCP) [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    At each clinic / occupational therapy visit, a blinded assessor will determine the total range of motion of the finger DIP, PIP and MCP joints


Secondary Outcome Measures:
  • Compliance with therapy [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    At each clinic and occupational therapy visit, an assessor will ask the patient if they have been compliant with therapy

  • Rupture [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    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

  • Infection [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    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.

  • Attendance with follow-up clinic and occupational therapy [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    The patient's attendance will be determined at each clinic or occupational therapy visit.

  • Use of oral analgesics [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    At each clinic visit, the patient will be asked if they are still using oral analgesics

  • Oral antibiotic usage [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    At each clinic visit, the patient will be asked if they are using oral antibiotics.

  • Wound dehiscence (breakdown) [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    At each clinic and occupational therapy visit, the patient will be assessed to determine if a wound dehiscence (breakdown) has occurred.

  • Use of occupational therapy adjunctive treatments [ Time Frame: Post-operative weeks 1, 2, 4, 6 and 12 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 24
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344980

Contacts
Contact: Leif J Sigurdson, MD 204-787-7374 lsigurdson2@exchange.hsc.mb.ca
Contact: Ian R MacArthur, MD 204-990-6397 i_macarthur@shaw.ca

Locations
Canada, Manitoba
Health Sciences Center Not yet recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Leif J Sigurdson, MD    204-787-7374    Leif Sigurdson <lsigurdson2@exchange.hsc.mb.ca>   
Principal Investigator: Ian R MacArthur, MD         
Sub-Investigator: Sarvesh Logsetty, MD         
Sub-Investigator: Leif J Sigurdson, MD         
Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: Ian MacArthur (principle investigator), University of Manitoba: Department of Surgery: Section of Plastic Surgery
ClinicalTrials.gov Identifier: NCT01344980     History of Changes
Other Study ID Numbers: B2010:119
Study First Received: April 28, 2011
Last Updated: April 28, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014