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Labral Repair vs Reconstruction

27. august 2026 oppdatert av: Western University, Canada

Labral Repair Versus Reconstruction in Symptomatic Femoroacetabular Impingement in Patients Over 40 Years of Age - A Randomized Controlled Trial

The purpose of this pilot study is to determine feasibility of a randomized controlled trial comparing labral repair versus reconstruction in patients over 40 years of age undergoing hip arthroscopy for FAIS. Specifically, the investigators aim to: (1) estimate the proportion of eligible patients providing consent, (2) estimate the magnitude of the between-groups difference in the primary outcome (International Hip Outcome Tool [iHOT] - 33) to aid in sample size calculation for the full study, (3) estimate the compliance in completing the proposed outcome measures to determine the burden of questionnaire completion.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

Femoroacetabular impingement syndrome (FAIS) is an increasingly common cause hip pain. It is known to cause labral pathology and if left untreated, can also contribute to the development of hip osteoarthritis. While non-operative treatment has been shown to be effective and can improve patients' quality of life, surgical treatment has often been shown to yield superior outcomes, while also potentially decreasing the future risk of osteoarthritis.

Mid- to long-term outcomes have shown durable results following hip arthroscopy with significant improvements in patient reported outcome measures (PROMs). Consequently, hip arthroscopy utilization has continued to increase. Several retrospective cohort studies have attempted to identify prognostic variables associated with procedural outcomes. In terms of patient selection, age has historically been identified as a negative prognostic variable, with inferior clinical outcomes observed in patients over the age of 40. However, more recent studies have disputed this finding, suggesting that earlier studies reporting this included patients with concomitant hip osteoarthritis, which was more to blame than their chronological age. Recent case series have reported significant improvements in PROMs in patients over the age of 40 who have minimal concomitant OA (Tönnis 0 or 1), with durable results out to 5 years14-16.

Despite these encouraging results, newer concerns have been raised when it comes to labral treatment in this demographic. It has been suggested that in patients over 40 years of age, the labrum may be too traumatized to allow repair or that it may have diminished healing capacity from repetitive impingement or age-related degeneration. As such, there have been proponents of performing a primary labral reconstruction in this patient population, with better associated outcomes. Others have reported equivocal outcomes between repair and reconstruction for this group. As such, there is no consensus on the best treatment strategy to manage these patients.

The results of this pilot study will allow the investigators to determine whether a full-scale study will be feasible. The investigators will not move forward with the full study: 1) if the proportion of eligible patients providing consent is <80%; 2) If the 95% confidence intervals around the difference between groups does not include even the possibility of a small, but important effect (0.2 SD); 3) if the proportion of patients completing their one-year follow-up is <85%, then the study is not feasible.

Ultimately, for the full-scale study, the investigators hypothesize that patients treated with labral reconstruction will have significantly better outcome scores compared with patients who underwent a traditional labral repair. If the hypothesized findings are true in the full study, this will change clinical practice patterns by providing objective evidence to guide treatment of labral pathology in patients over the age of 40 undergoing hip arthroscopy for FAIS.

Studietype

Intervensjonell

Registrering (Antatt)

220

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sport Medicine Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ryan Degen

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion:

-Cam or pincer morphology who have failed a trial of conservative treatment

Exclusion:

  • Moderate concomitant OA (Tönnis 2+)
  • Have had previous hip surgery
  • Active joint or systemic infection
  • Significant muscle paralysis
  • Inflammatory arthropathies
  • Significant medical comorbidity that may alter effectiveness of surgical intervention
  • Active smoker
  • Major medical illness
  • Unable to speak and understand English
  • Psychiatric illness that precludes informed consent
  • Unwilling to be followed for 2 years

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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Labral Repair
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
Aktiv komparator: Labral Reconstruction
Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
International Hip Outcome Tool (iHOT) - 12
Tidsramme: Baseline to 2 years post surgical follow-up
Baseline to 2 years post surgical follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Hip Outcome Score- Activities of Daily Living (HOS-ADL)
Tidsramme: Baseline to 2 years post surgical follow-up
Baseline to 2 years post surgical follow-up
Hip Outcome Score- Sport Specific Subscale (HOS-SSS)
Tidsramme: Baseline to 2 years post surgical follow-up
Baseline to 2 years post surgical follow-up
modified Harris Hip Score (mHHS)
Tidsramme: Baseline to 2 years post surgical follow-up
Baseline to 2 years post surgical follow-up
EQ-5D
Tidsramme: Baseline to 2 years post surgical follow-up
Baseline to 2 years post surgical follow-up
Cost Diary
Tidsramme: 6 weeks to 2 years post surgical follow-up
6 weeks to 2 years post surgical follow-up
Patient Satisfaction Scale
Tidsramme: 6 weeks to 2 years post surgical follow-up
6 weeks to 2 years post surgical follow-up
Post-operative complication rates
Tidsramme: 6 weeks to 2 years post surgical follow-up
6 weeks to 2 years post surgical follow-up
Subsequent surgery rates
Tidsramme: 6 weeks to 2 years post surgical follow-up
6 weeks to 2 years post surgical follow-up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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 (Antatt)

1. september 2026

Primær fullføring (Antatt)

30. september 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

19. mai 2026

Først innsendt som oppfylte QC-kriteriene

19. mai 2026

Først lagt ut (Faktiske)

27. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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