Total Hip Arthroplasty (THA)
Conditions
Brief summary
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.
Interventions
PROCEDURELabrum Preservation
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.
PROCEDURELabrum Excision
The acetabular labrum will be removed during surgery, prior to final cup placement.
Sponsors
Total Joint Specialists
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS) | 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. |
| Veterans RAND 12-Item Health Survey (VR-12) Mental Component Score (MCS) | 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. |
| Procedure Satisfaction (5-Point Likert Scale) | 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. |
| Numeric Pain Rating Scale (NPRS) | 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. |
| HOOS, JR. (Hip Disability and Osteoarthritis Outcome Score for Joint Replacement) | 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. |
| Forgotten Joint Score-12 (FJS-12) | 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. |
| Intraoperative Soft-Tissue/Labral Interference with Cup Position | 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. |
| Protocol Deviation Rate (Labral Removal in Preservation Arm) | 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. |
| Operative Time | 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. |
| Total Fluoroscopy Time | Intraoperative (at time of surgery) | Total fluoroscopy time recorded during the surgical procedure, compared between labrum excision and labrum preservation groups. |
| Incidence of Supplemental Acetabular Screw Use | Intraoperative (at time of surgery) | Proportion of patients requiring supplemental acetabular screws for component fixation, compared between labrum excision and labrum preservation groups. |
| Estimated Blood Loss (EBL) | Intraoperative (at time of surgery) | Estimated intraoperative blood loss, compared between labrum excision and labrum preservation groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iliopsoas Pain | Within 90 days postoperatively | Incidence of iliopsoas pain reported within 90 days after surgery, compared between labrum excision and labrum preservation groups. |
| Instability | 90 days and 1 year postoperatively | Incidence of postoperative hip instability, compared between labrum excision and labrum preservation groups. |
| Dislocation | 90 days and 1 year postoperatively | Incidence of postoperative hip dislocation, compared between labrum excision and labrum preservation groups. |
| Periprosthetic Joint Infection (PJI) | 90 days and 1 year postoperatively | Incidence of periprosthetic joint infection, compared between labrum excision and labrum preservation groups. |
| Reoperation | 90 days and 1 year postoperatively | Incidence of reoperation for any cause, compared between labrum excision and labrum preservation groups. |
| All-Cause Revision | 90 days and 1 year postoperatively | Incidence of revision surgery for any cause, compared between labrum excision and labrum preservation groups. |
| Wound Complications | 90 days and 1 year postoperatively | Incidence of postoperative wound complications, compared between labrum excision and labrum preservation groups. |
| Venous Thromboembolism (DVT/PE) | 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. |
| Readmission | 90 days and 1 year postoperatively | Incidence of hospital readmission, compared between labrum excision and labrum preservation groups. |
Countries
United States
Outcome results
None listed