Zone 2 Flexor Tendon Lacerations of the HandPhase 2NCT01344980
The Effects of a Stainless Steel Suture MGH Flexor Tendon Repair Coupled With Early Aggressive Range of Motion Rehabilitation: a Randomized Controlled Trial
A Phase 2 study testing Stainless steel suture, Polypropylene suture and Aggressive early active range of motion rehabilitation in people with Zone 2 Flexor Tendon Lacerations of the Hand, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Zone 2 Flexor Tendon Lacerations of the Hand
- What is being tested?
- Stainless steel suture, Polypropylene suture and Aggressive early active range of motion rehabilitation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults
- living in Winnipeg, Manitoba
- zone II flexor tendon lacerations in a single finger
- able to consent to and comply with surgery
Who cannot join
- crush injuries
- vascular injuries requiring re-vascularization
- fractures
- infection
- prior hand injury requiring surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences Center
Winnipeg, Manitoba, R3A 1R9
Leif J Sigurdson, MD, 204-787-7374, Leif Sigurdson <lsigurdson2@exchange.hsc.mb.ca>
Ian R MacArthur, MD
About this study
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
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.
Read the 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.
- Being tested
- Stainless steel suture, Polypropylene suture, Aggressive early active range of motion rehabilitation, Early active range of motion rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stainless steel sutureProcedure or surgery
Stainless steel suture material will be used (size 3-0) in an MGH repair technique
Polypropylene sutureProcedure or surgery
Polypropylene suture (size 3-0) will be used in a double-locking loop repair technique
Aggressive early active range of motion rehabilitationBehavioural
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 rehabilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Stainless steel suture; Behavioral: 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. Receives: Procedure: Polypropylene suture; Behavioral: Early active range of motion rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Post-operative weeks 1, 2, 4, 6 and 12
Secondary outcomes (8)
Compliance with therapy
At each clinic and occupational therapy visit, an assessor will ask the patient if they have been compliant with therapy
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Post-operative weeks 1, 2, 4, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zone 2 Flexor Tendon Lacerations of the HandStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344980
- Sponsor's protocol ID
- B2010:119
- Status last verified
- Feb 2011
- First submitted
- 28 Apr 2011
- Last updated
- 29 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01344980
- Acronym / sponsor ID
- B2010:119
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stainless steel MGH | Experimental | Procedure: Stainless steel suture, Behavioral: Aggressive early active range of motion rehabilitationPatients 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. |
| Polypropylene DOLL | Active comparator | Procedure: Polypropylene suture, Behavioral: Early active range of motion rehabilitationPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults
- living in Winnipeg, Manitoba
- zone II flexor tendon lacerations in a single finger
- able to consent to and comply with surgery
Key exclusion criteria (5 listed)
- crush injuries
- vascular injuries requiring re-vascularization
- fractures
- infection
- prior hand injury requiring surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stainless steel sutureStainless steel suture material will be used (size 3-0) in an MGH repair technique | Procedure or surgery | Stainless steel MGH |
| Polypropylene suturePolypropylene suture (size 3-0) will be used in a double-locking loop repair technique | Procedure or surgery | Polypropylene DOLL |
| Aggressive early active range of motion rehabilitationPatients 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. | Behavioural | Stainless steel MGH |
| Early active range of motion rehabilitationPatients 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 | Behavioural | Polypropylene DOLL |
Primary outcome
Return to work
Time frame: Post-operative weeks 1, 2, 4, 6 and 12
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
At each clinic / occupational therapy visit, a blinded assessor will determine the total range of motion of the finger DIP, PIP and MCP joints
8 secondary outcomes
Compliance with therapy
Time frame: Post-operative weeks 1, 2, 4, 6 and 12
Rupture
Time frame: Post-operative weeks 1, 2, 4, 6 and 12
Infection
Time frame: Post-operative weeks 1, 2, 4, 6 and 12
Attendance with follow-up clinic and occupational therapy
Time frame: Post-operative weeks 1, 2, 4, 6 and 12
Use of oral analgesics
Time frame: Post-operative weeks 1, 2, 4, 6 and 12
Oral antibiotic usage
Time frame: Post-operative weeks 1, 2, 4, 6 and 12
Wound dehiscence (breakdown)
Time frame: Post-operative weeks 1, 2, 4, 6 and 12
Use of occupational therapy adjunctive treatments
Time frame: Post-operative weeks 1, 2, 4, 6 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stainless steel suture, Polypropylene suture and Aggressive early active range of motion rehabilitation in people with Zone 2 Flexor Tendon Lacerations of the Hand, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leif J Sigurdson, MD (204-787-7374, lsigurdson2@exchange.hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to work (time frame: Post-operative weeks 1, 2, 4, 6 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2011.