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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 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

24

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: Stainless steel suture
Stainless steel suture material will be used (size 3-0) in an MGH repair technique
Verhalten: 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.
Aktiver 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.
Verfahren: Polypropylene suture
Polypropylene suture (size 3-0) will be used in a double-locking loop repair technique
Verhalten: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Return to work
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Compliance with therapy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Manitoba

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2011

Primärer Abschluss (Voraussichtlich)

1. Juni 2012

Studienabschluss (Voraussichtlich)

1. Juni 2013

Studienanmeldedaten

Zuerst eingereicht

28. April 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. April 2011

Zuerst gepostet (Schätzen)

29. April 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

29. April 2011

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. April 2011

Zuletzt verifiziert

1. Februar 2011

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • B2010:119

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