NCT01344980

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 29, 2011

Status Verified

February 1, 2011

Enrollment Period

1 year

First QC Date

April 28, 2011

Last Update Submit

April 28, 2011

Conditions

Zone 2 Flexor Tendon Lacerations of the Hand

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Compliance with therapy

    Post-operative weeks 1, 2, 4, 6 and 12

  • Rupture

    Post-operative weeks 1, 2, 4, 6 and 12

  • Infection

    Post-operative weeks 1, 2, 4, 6 and 12

  • Attendance with follow-up clinic and occupational therapy

    Post-operative weeks 1, 2, 4, 6 and 12

  • Use of oral analgesics

    Post-operative weeks 1, 2, 4, 6 and 12

  • +3 more secondary outcomes

Study Arms (2)

Stainless steel MGH

EXPERIMENTAL

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 sutureBehavioral: Aggressive early active range of motion rehabilitation

Polypropylene DOLL

ACTIVE COMPARATOR

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 sutureBehavioral: Early active range of motion rehabilitation

Interventions

Stainless steel suturePROCEDURE

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

Stainless steel MGH
Polypropylene suturePROCEDURE

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

Polypropylene DOLL
Aggressive early active range of motion rehabilitationBEHAVIORAL

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.

Stainless steel MGH
Early active range of motion rehabilitationBEHAVIORAL

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

Polypropylene DOLL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • crush injuries
  • vascular injuries requiring re-vascularization
  • fractures
  • infection
  • prior hand injury requiring surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Center

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Central Study Contacts

Leif J Sigurdson, MD

CONTACT

204-787-7374lsigurdson2@exchange.hsc.mb.ca

Ian R MacArthur, MD

CONTACT

204-990-6397i_macarthur@shaw.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2011

First Posted

April 29, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

April 29, 2011

Record last verified: 2011-02

Locations

CA(1)