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

Zone 2 Flexor Tendon Lacerations of the Hand Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01344980
• Other study ID #: B2010:119
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 28, 2011
• Last updated: April 28, 2011
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2011
• Source: University of Manitoba
• Contact: Leif J Sigurdson, MD
• Phone: 204-787-7374
• Email: lsigurdson2[@]exchange.hsc.mb.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Lacerations
• Zone 2 Flexor Tendon Lacerations of the Hand

Intervention

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

Locations

Country	Name	City	State
Canada	Health Sciences Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No