Clinical trial NCT01344980: The Effects of a Stainless Steel Suture MGH Flexor Tendon Repair Coupled With Early Aggressive Range of Motion Rehabilitation: a Randomized Controlled 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Zone 2 Flexor Tendon Lacerations of the Hand
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Return to work
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
measure: Finger joint range of motion (PIP, DIP, MCP)
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
Secondary outcomes:
measure: Compliance with therapy
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
measure: Rupture
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
measure: Infection
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
measure: Attendance with follow-up clinic and occupational therapy
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
measure: Use of oral analgesics
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
measure: Oral antibiotic usage
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
measure: Wound dehiscence (breakdown)
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
measure: Use of occupational therapy adjunctive treatments
timeFrame: Post-operative weeks 1, 2, 4, 6 and 12
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Center
state: Manitoba
Study officials:
References: