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 oppdatert 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.
Studieoversikt
Status
Ukjent
Detaljert beskrivelse
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
Intervensjonell
Registrering (Forventet)
24
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Health Sciences Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Return to work
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Compliance with therapy
Tidsramme: 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
Tidsramme: 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
|
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Infection
Tidsramme: 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.
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Post-operative weeks 1, 2, 4, 6 and 12
|
|
Attendance with follow-up clinic and occupational therapy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Wound dehiscence (breakdown)
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2011
Primær fullføring (Forventet)
1. juni 2012
Studiet fullført (Forventet)
1. juni 2013
Datoer for studieregistrering
Først innsendt
28. april 2011
Først innsendt som oppfylte QC-kriteriene
28. april 2011
Først lagt ut (Anslag)
29. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. april 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. april 2011
Sist bekreftet
1. februar 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B2010:119
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