Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

The Effects of a Stainless Steel Suture MGH Flexor Tendon Repair Coupled With Early Aggressive Range of Motion Rehabilitation: a Randomized Controlled Trial

28 aprile 2011 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

24

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: Stainless steel suture
Stainless steel suture material will be used (size 3-0) in an MGH repair technique
Comportamentale: Aggressive early active range of motion rehabilitation
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.
Comparatore attivo: 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.
Procedura: Polypropylene suture
Polypropylene suture (size 3-0) will be used in a double-locking loop repair technique
Comportamentale: Early active range of motion rehabilitation
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Return to work
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Compliance with therapy
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Manitoba

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2011

Completamento primario (Anticipato)

1 giugno 2012

Completamento dello studio (Anticipato)

1 giugno 2013

Date di iscrizione allo studio

Primo inviato

28 aprile 2011

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2011

Primo Inserito (Stima)

29 aprile 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 aprile 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2011

Ultimo verificato

1 febbraio 2011

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B2010:119

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Stainless steel suture

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Romania

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi