- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07608237
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.
Labral Repair Versus Reconstruction in Symptomatic Femoroacetabular Impingement in Patients Over 40 Years of Age - A Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Femoroacetabular impingement syndrome (FAIS) is an increasingly common cause hip pain1. It is known to cause labral pathology and if left untreated, can also contribute to the development of hip osteoarthritis2. 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 osteoarthritis3,4,5,6.
Mid- to long-term outcomes have shown durable results following hip arthroscopy with significant improvements in patient reported outcome measures (PROMs)7,8. Consequently, hip arthroscopy utilization has continued to increase. Several retrospective cohort studies have attempted to identify prognostic variables associated with procedural outcomes9-11. 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 4012,13. 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 17,18 . As such, there have been proponents of performing a primary labral reconstruction in this patient population, with better associated outcomes18. Others have reported equivocal outcomes between repair and reconstruction for this group19. As such, there is no consensus on the best treatment strategy to manage these patients.
The results of this pilot study will allow us to determine whether a full-scale study will be feasible. We 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, we 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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ontario
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London, Ontario, Canada, N6A 3K7
- Fowler Kennedy Sport Medicine Clinic
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Contatto:
- Ashley Ambrose
- Numero di telefono: 87528 5196612111
- Email: ashley.ambrose@lhsc.on.ca
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Investigatore principale:
- Ryan Degen
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Labral Repair
Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
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Standard arthroscopic osteochondroplasty and concomitant labral repair, using a minimum of two suture anchors.
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Comparatore attivo: Labral Reconstruction
Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
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Standard arthroscopic osteochondroplasty and subsequent labral reconstruction with allograft.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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International Hip Outcome Tool (iHOT) - 12
Lasso di tempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Hip Outcome Score- Activities of Daily Living (HOS-ADL)
Lasso di tempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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Hip Outcome Score- Sport Specific Subscale (HOS-SSS)
Lasso di tempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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modified Harris Hip Score (mHHS)
Lasso di tempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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EQ-5D
Lasso di tempo: Baseline to 2 years post surgical follow-up
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Baseline to 2 years post surgical follow-up
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Cost Diary
Lasso di tempo: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Patient Satisfaction Scale
Lasso di tempo: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Post-operative complication rates
Lasso di tempo: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Subsequent surgery rates
Lasso di tempo: 6 weeks to 2 years post surgical follow-up
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6 weeks to 2 years post surgical follow-up
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 127777
Informazioni su farmaci e dispositivi, documenti di studio
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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 Impingement acetabolare femorale
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Schulthess KlinikCompletatoImpingement femoroacetabolare sintomaticoSvizzera
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Peking University Third HospitalCompletatoImpingement femoro-acetabolare (FAI)Cina
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GCS Ramsay Santé pour l'Enseignement et la RechercheNon ancora reclutamentoImpingement femoroacetabolareFrancia
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Ottawa Hospital Research InstituteCompletatoFemoroacetabolare, ImpingementCanada
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University of OxfordOxford University Hospitals NHS TrustNon ancora reclutamentoImpingement acetabolare femoraleRegno Unito
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Ramsay Générale de SantéRamsay santéReclutamento
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Horsens HospitalUniversity of Aarhus; La Trobe UniversityCompletatoImpingement femoroacetabolareDanimarca
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Universitaire Ziekenhuizen KU LeuvenCompletatoImpingement femoroacetabolareBelgio
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American Hip InstituteStryker OrthopaedicsAttivo, non reclutanteImpingement femoroacetabolareStati Uniti
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The Hawkins FoundationTerminato
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-
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-
Reckitt Benckiser Healthcare (UK) LimitedIntertekCompletato
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GSVM Medical CollegeCompletato
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ChinaNormNon ancora reclutamento
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Ain Shams UniversityIscrizione su invito
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Reckitt Benckiser Healthcare (UK) LimitedSkin Investigation TechnologyCompletato
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AronPharma Sp. z o. o.Reclutamento
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Lei LiSconosciutoNeoplasie colorettali, non poliposi ereditarie | Neoplasie endometrialiCina
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Medtronic - MITGAttivo, non reclutanteErnia inguinale | Ernia ventraleStati Uniti