Comparing Outcomes of Labrum Preservation vs Excision in Primary Total Hip Arthroplasty
3 września 2026 zaktualizowane przez: Total Joint Specialists
Labral Excision vs Preservation in Primary Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
This research is being done to determine whether removing or preserving the acetabular labrum, a ring of cartilage around the hip socket, during hip replacement surgery affects post-operative outcomes, operative time, or ease of placing the hip implant.
Both techniques (labrum removal and labrum preservation) are commonly performed by surgeons during total hip arthroplasty (THA). However, there is no definitive evidence showing whether one approach is better than the other. The goal of this study is to compare recovery and surgical factors between these two routinely used methods.
Przegląd badań
Status
Rejestracja na zaproszenie
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
200
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Georgia
-
Sandy Springs, Georgia, Stany Zjednoczone, 30328
- Total Joint Surgery Center Atlanta
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- Age ≥ 18 years.
- Indication for primary unilateral total hip arthroplasty for osteoarthritis (Tonnis grade ≥2 or surgeon's standard indication).
- Able to provide informed consent and complete PROMs in English (or validated local language instruments).
Exclusion Criteria:
- Prior ipsilateral hip replacement or resurfacing.
- Active infection or inflammatory arthritis where labral management is judged by the surgeon to be non-standard.
- Severe acetabular bone loss or deformity requiring custom implants or complex reconstruction (Crowe III/IV dysplasia).
- Planned simultaneous bilateral hip arthroplasty.
- Preoperative heterotopic ossification.
- Cognitive impairment preventing consent or completion of PROMs.
- Patients for whom the surgeon believes leaving the labrum would be unsafe (e.g., gross interposed soft tissue preventing any reasonable cup placement without removal)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Group A: Labrum Excision
This group has their labrum excised, with is the standard of care for THA.
|
The acetabular labrum will be removed during surgery, prior to final cup placement.
|
|
Eksperymentalny: Group B: Labrum Preservation
The experimental group to test recovery outcomes from preserving the labrum.
|
The acetabular labrum will be left in place during surgery unless it physically prevents proper implant seating, in which case it may be trimmed as necessary.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS)
Ramy czasowe: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
Change in physical health status measured by the Veterans RAND 12-Item Health Survey (VR-12), Physical Component Score.
Scores range from 0 to 100, with higher scores indicating better physical health status.
Compared between labrum excision and labrum preservation groups.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
Veterans RAND 12-Item Health Survey (VR-12) Mental Component Score (MCS)
Ramy czasowe: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
Change in mental health status measured by the Veterans RAND 12-Item Health Survey (VR-12), Mental Component Score.
Scores range from 0 to 100, with higher scores indicating better mental health status.
Compared between labrum excision and labrum preservation groups.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
Procedure Satisfaction (5-Point Likert Scale)
Ramy czasowe: 12 weeks postoperatively
|
Patient-reported satisfaction with the surgical procedure, assessed via a 5-point Likert scale at 12 weeks postoperatively.
Scores range from 1 (Very Dissatisfied) to 5 (Very Satisfied), with higher scores indicating greater satisfaction.
Compared between labrum excision and labrum preservation groups.
|
12 weeks postoperatively
|
|
Numeric Pain Rating Scale (NPRS)
Ramy czasowe: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
Patient-reported pain intensity measured by the Numeric Pain Rating Scale, an 11-point scale ranging from 0 to 10, with higher scores indicating worse (greater) pain.
Compared between labrum excision and labrum preservation groups.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
HOOS, JR. (Hip Disability and Osteoarthritis Outcome Score for Joint Replacement)
Ramy czasowe: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
Change in hip-specific patient-reported outcome measured by the Hip disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR.).
Scores range from 0 to 100, with higher scores indicating better hip function and less disability.
Compared between labrum excision and labrum preservation groups.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
Forgotten Joint Score-12 (FJS-12)
Ramy czasowe: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
Change in joint awareness during daily activities measured by the Forgotten Joint Score-12 (FJS-12).
Scores range from 0 to 100, with higher scores indicating better outcomes (less awareness of the joint, i.e., the joint is more "forgotten").
Compared between labrum excision and labrum preservation groups.
|
Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
|
|
Intraoperative Soft-Tissue/Labral Interference with Cup Position
Ramy czasowe: Intraoperative (at time of surgery)
|
Surgeon-judged determination (yes/no) of whether soft tissue or the labrum interfered with acetabular cup positioning during the procedure, compared between groups.
|
Intraoperative (at time of surgery)
|
|
Protocol Deviation Rate (Labral Removal in Preservation Arm)
Ramy czasowe: Intraoperative (at time of surgery)
|
Incidence of labral removal in patients randomized to the labrum preservation arm, performed per the predefined protocol deviation criteria when needed for safe cup or liner seating.
These cases remain in the intention-to-treat analysis and are also assessed in a per-protocol sensitivity analysis.
|
Intraoperative (at time of surgery)
|
|
Operative Time
Ramy czasowe: Intraoperative (at time of surgery)
|
Total surgical time in minutes from skin incision to skin closure, recorded from the operative record and compared between labrum excision and labrum preservation groups.
|
Intraoperative (at time of surgery)
|
|
Total Fluoroscopy Time
Ramy czasowe: Intraoperative (at time of surgery)
|
Total fluoroscopy time recorded during the surgical procedure, compared between labrum excision and labrum preservation groups.
|
Intraoperative (at time of surgery)
|
|
Incidence of Supplemental Acetabular Screw Use
Ramy czasowe: Intraoperative (at time of surgery)
|
Proportion of patients requiring supplemental acetabular screws for component fixation, compared between labrum excision and labrum preservation groups.
|
Intraoperative (at time of surgery)
|
|
Estimated Blood Loss (EBL)
Ramy czasowe: Intraoperative (at time of surgery)
|
Estimated intraoperative blood loss, compared between labrum excision and labrum preservation groups.
|
Intraoperative (at time of surgery)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Iliopsoas Pain
Ramy czasowe: Within 90 days postoperatively
|
Incidence of iliopsoas pain reported within 90 days after surgery, compared between labrum excision and labrum preservation groups.
|
Within 90 days postoperatively
|
|
Instability
Ramy czasowe: 90 days and 1 year postoperatively
|
Incidence of postoperative hip instability, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Dislocation
Ramy czasowe: 90 days and 1 year postoperatively
|
Incidence of postoperative hip dislocation, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Periprosthetic Joint Infection (PJI)
Ramy czasowe: 90 days and 1 year postoperatively
|
Incidence of periprosthetic joint infection, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Reoperation
Ramy czasowe: 90 days and 1 year postoperatively
|
Incidence of reoperation for any cause, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
All-Cause Revision
Ramy czasowe: 90 days and 1 year postoperatively
|
Incidence of revision surgery for any cause, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Wound Complications
Ramy czasowe: 90 days and 1 year postoperatively
|
Incidence of postoperative wound complications, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Venous Thromboembolism (DVT/PE)
Ramy czasowe: 90 days and 1 year postoperatively
|
Incidence of venous thromboembolism, including deep vein thrombosis and pulmonary embolism, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
|
Readmission
Ramy czasowe: 90 days and 1 year postoperatively
|
Incidence of hospital readmission, compared between labrum excision and labrum preservation groups.
|
90 days and 1 year postoperatively
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
7 lipca 2026
Zakończenie podstawowe (Szacowany)
1 lipca 2027
Ukończenie studiów (Szacowany)
1 lipca 2028
Daty rejestracji na studia
Pierwszy przesłany
22 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 września 2026
Pierwszy wysłany (Rzeczywisty)
10 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
10 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- NSH1444
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .