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 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
24
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R3A 1R9
- Health Sciences Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Return to work
Tidsram: 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)
|
Post-operative weeks 1, 2, 4, 6 and 12
|
|
Finger joint range of motion (PIP, DIP, MCP)
Tidsram: 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
|
Post-operative weeks 1, 2, 4, 6 and 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Compliance with therapy
Tidsram: Post-operative weeks 1, 2, 4, 6 and 12
|
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
|
|
Rupture
Tidsram: Post-operative weeks 1, 2, 4, 6 and 12
|
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
|
|
Infection
Tidsram: Post-operative weeks 1, 2, 4, 6 and 12
|
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
|
|
Attendance with follow-up clinic and occupational therapy
Tidsram: Post-operative weeks 1, 2, 4, 6 and 12
|
The patient's attendance will be determined at each clinic or occupational therapy visit.
|
Post-operative weeks 1, 2, 4, 6 and 12
|
|
Use of oral analgesics
Tidsram: Post-operative weeks 1, 2, 4, 6 and 12
|
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
|
|
Oral antibiotic usage
Tidsram: Post-operative weeks 1, 2, 4, 6 and 12
|
At each clinic visit, the patient will be asked if they are using oral antibiotics.
|
Post-operative weeks 1, 2, 4, 6 and 12
|
|
Wound dehiscence (breakdown)
Tidsram: Post-operative weeks 1, 2, 4, 6 and 12
|
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
|
|
Use of occupational therapy adjunctive treatments
Tidsram: Post-operative weeks 1, 2, 4, 6 and 12
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2011
Primärt slutförande (Förväntat)
1 juni 2012
Avslutad studie (Förväntat)
1 juni 2013
Studieregistreringsdatum
Först inskickad
28 april 2011
Först inskickad som uppfyllde QC-kriterierna
28 april 2011
Första postat (Uppskatta)
29 april 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 april 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 april 2011
Senast verifierad
1 februari 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B2010:119
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .