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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
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.
The acetabular labrum will be removed during surgery, prior to final cup placement.
Total Joint Surgery Center Atlanta
Sandy Springs, Georgia, United States
Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS)
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.
Time frame: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
Veterans RAND 12-Item Health Survey (VR-12) Mental Component Score (MCS)
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.
Time frame: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
Procedure Satisfaction (5-Point Likert Scale)
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.
Time frame: 12 weeks postoperatively
Numeric Pain Rating Scale (NPRS)
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.
Time frame: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
HOOS, JR. (Hip Disability and Osteoarthritis Outcome Score for Joint Replacement)
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.
Time frame: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
Forgotten Joint Score-12 (FJS-12)
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.
Time frame: Baseline (preoperative), 6 weeks, 6 months, and 1 year postoperatively
Intraoperative Soft-Tissue/Labral Interference with Cup Position
Surgeon-judged determination (yes/no) of whether soft tissue or the labrum interfered with acetabular cup positioning during the procedure, compared between groups.
Time frame: Intraoperative (at time of surgery)
Protocol Deviation Rate (Labral Removal in Preservation Arm)
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.
Time frame: Intraoperative (at time of surgery)
Operative Time
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.
Time frame: Intraoperative (at time of surgery)
Total Fluoroscopy Time
Total fluoroscopy time recorded during the surgical procedure, compared between labrum excision and labrum preservation groups.
Time frame: Intraoperative (at time of surgery)
Incidence of Supplemental Acetabular Screw Use
Proportion of patients requiring supplemental acetabular screws for component fixation, compared between labrum excision and labrum preservation groups.
Time frame: Intraoperative (at time of surgery)
Estimated Blood Loss (EBL)
Estimated intraoperative blood loss, compared between labrum excision and labrum preservation groups.
Time frame: Intraoperative (at time of surgery)
Iliopsoas Pain
Incidence of iliopsoas pain reported within 90 days after surgery, compared between labrum excision and labrum preservation groups.
Time frame: Within 90 days postoperatively
Instability
Incidence of postoperative hip instability, compared between labrum excision and labrum preservation groups.
Time frame: 90 days and 1 year postoperatively
Dislocation
Incidence of postoperative hip dislocation, compared between labrum excision and labrum preservation groups.
Time frame: 90 days and 1 year postoperatively
Periprosthetic Joint Infection (PJI)
Incidence of periprosthetic joint infection, compared between labrum excision and labrum preservation groups.
Time frame: 90 days and 1 year postoperatively
Reoperation
Incidence of reoperation for any cause, compared between labrum excision and labrum preservation groups.
Time frame: 90 days and 1 year postoperatively
All-Cause Revision
Incidence of revision surgery for any cause, compared between labrum excision and labrum preservation groups.
Time frame: 90 days and 1 year postoperatively
Wound Complications
Incidence of postoperative wound complications, compared between labrum excision and labrum preservation groups.
Time frame: 90 days and 1 year postoperatively
Venous Thromboembolism (DVT/PE)
Incidence of venous thromboembolism, including deep vein thrombosis and pulmonary embolism, compared between labrum excision and labrum preservation groups.
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Time frame: 90 days and 1 year postoperatively
Readmission
Incidence of hospital readmission, compared between labrum excision and labrum preservation groups.
Time frame: 90 days and 1 year postoperatively