The Effects of a Stainless Steel Suture MGH Flexor Tendon Repair Coupled With Early Aggressive Range of Motion Rehabilitation: a Randomized Controlled Trial
28 april 2011 bijgewerkt door: University of Manitoba
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.
Studie Overzicht
Toestand
Onbekend
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
24
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Health Sciences Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Stainless steel suture material will be used (size 3-0) in an MGH repair technique
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.
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Actieve vergelijker: 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.
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Polypropylene suture (size 3-0) will be used in a double-locking loop repair technique
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
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Return to work
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic visit at the above mentioned time periods, the clinician will ask the patient if they have returned to work (if applicable)
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Post-operative weeks 1, 2, 4, 6 and 12
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Finger joint range of motion (PIP, DIP, MCP)
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic / occupational therapy visit, a blinded assessor will determine the total range of motion of the finger DIP, PIP and MCP joints
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Post-operative weeks 1, 2, 4, 6 and 12
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Compliance with therapy
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic and occupational therapy visit, an assessor will ask the patient if they have been compliant with therapy
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Post-operative weeks 1, 2, 4, 6 and 12
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Rupture
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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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
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Post-operative weeks 1, 2, 4, 6 and 12
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Infection
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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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.
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Post-operative weeks 1, 2, 4, 6 and 12
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Attendance with follow-up clinic and occupational therapy
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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The patient's attendance will be determined at each clinic or occupational therapy visit.
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Post-operative weeks 1, 2, 4, 6 and 12
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Use of oral analgesics
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic visit, the patient will be asked if they are still using oral analgesics
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Post-operative weeks 1, 2, 4, 6 and 12
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Oral antibiotic usage
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic visit, the patient will be asked if they are using oral antibiotics.
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Post-operative weeks 1, 2, 4, 6 and 12
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Wound dehiscence (breakdown)
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic and occupational therapy visit, the patient will be assessed to determine if a wound dehiscence (breakdown) has occurred.
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Post-operative weeks 1, 2, 4, 6 and 12
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Use of occupational therapy adjunctive treatments
Tijdsspanne: Post-operative weeks 1, 2, 4, 6 and 12
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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)
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Post-operative weeks 1, 2, 4, 6 and 12
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2011
Primaire voltooiing (Verwacht)
1 juni 2012
Studie voltooiing (Verwacht)
1 juni 2013
Studieregistratiedata
Eerst ingediend
28 april 2011
Eerst ingediend dat voldeed aan de QC-criteria
28 april 2011
Eerst geplaatst (Schatting)
29 april 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
29 april 2011
Laatste update ingediend die voldeed aan QC-criteria
28 april 2011
Laatst geverifieerd
1 februari 2011
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- B2010:119
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