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Rotator Cuff Injury to Surgery (RC-IS)

3. april 2017 opdateret af: Peter MacDonald, Panam Clinic

Effect of Surgical Wait Times on Outcomes of Rotator Cuff Surgery

The purpose of this prospective randomized controlled trial is to compare post-operative outcome between participants undergoing expedited surgery compared to those proceeding through a 'typical' wait time process. A secondary purpose is to evaluate the progression of rotator cuff tear size from the time of initial consult to the time of surgery.

Studieoversigt

Status

Trukket tilbage

Detaljeret beskrivelse

Consented patients will undergo a pre-operative assessment conducted by a study physiotherapist, including the following: 1) demographic information (age, gender, height, weight, smoking status, employment, recreational activities, time of injury, etc.); 2) shoulder ROM, 3) shoulder strength using a handheld dynamometer, and 4) subjective shoulder-specific outcome measures which include the Western Ontario Rotator Cuff Score (WORC), American Shoulder and Elbow Score (ASES), and Simple Shoulder Test (SST). Measurement of tear size will also be documented by an experienced radiologist from the initial MRI or ultrasound.

Patients will undergo initial consultation with the orthopaedic surgeon to confirm suitability for surgical management. If deemed appropriate to continue as a participant, the individual participants will be randomized to one of the two study groups. If in the Expedited group, the patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sports medicine physician. If randomized to the Control or 'Typical Wait Time' Group, surgery will take place no earlier than 9 months and no later than 12 months after the sports medicine physician consult.

Just prior to surgery, a second diagnostic imaging test will take place, either ultrasound or MRI, to document progress in tear size and any secondary pathology in the control group. Diagnostic test findings will be confirmed intraoperatively. All rotator cuff repairs will be performed by one of four fellowship trained orthopaedic surgeons.

The control study group will be sent the subjective questionnaires at 8 week intervals while they are waiting for surgery. Post-surgery study follow-ups will take place at 6, 12, and 24 months for both groups. All patients will be provided with the same rehabilitation protocol including pain management, range of motion and strengthening exercises. The same data as that collected pre-surgery will be repeated as well as any occurrences of failure of the repair. Failure of the repair is defined as ongoing severe pain, limited ROM, and/or decreased strength. If a failure occurs, follow-ups will continue until 24 months following failure or 24 months following revision surgery, if performed.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M3E4
        • Pan Am Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Between the ages of 45 and 70 years old
  • Acute full-thickness rotator cuff tear of supraspinatus an/or infraspinatus (as confirmed by appropriate diagnostic imagine)

Exclusion Criteria:

  • Presence of a tear of the subscapularis and/or teres minor;
  • Presence of a partial-thickness tear of the supraspinatus/infraspinatus;
  • Patient has undergone previous RC surgery to the affected shoulder;
  • Patient has an active WCB Claim or prior claim related to their shoulder;
  • Previous major joint trauma, infection, or avascular necrosis;
  • Chronic dislocation, inflammation, or degenerative glenohumeral arthropathy;
  • Evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
  • Psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
  • Major medical illness where life expectancy is less than 2 years;
  • Does not speak/read/understand English;
  • No fixed address or means of contact;
  • Unwillingness to complete necessary follow-ups

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Early Surgery
Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.
Eksperimentel: Regular Wait Time
Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Western Ontario Rotator Cuff
Tidsramme: 24 months
WORC score questionnaire is a tool designed for self-assessment of shoulder function for patients with rotator cuff problems. Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate
24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
American Shoulder and Elbow Surgeons (ASES)
Tidsramme: 24 months
The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function. Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate
24 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Injury to Surgery Time
Tidsramme: 24 months
Time will be calculated from initial injury to consultation to surgery.
24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Jeff Leiter, MSc, PhD, Pan Am Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Forventet)

1. januar 2017

Studieafslutning (Forventet)

1. januar 2018

Datoer for studieregistrering

Først indsendt

4. december 2012

Først indsendt, der opfyldte QC-kriterier

4. december 2012

Først opslået (Skøn)

6. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B2012:112

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rivning af rotatormanchet

Kliniske forsøg med Early Surgery

3
Abonner