Comparing Outcomes of Labrum Preservation vs Excision in Primary Total Hip Arthroplasty

NCT07812025 | Enrolling By Invitation

• 1 other identifier: NSH1444
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty (THA)

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Intraoperative (at time of surgery)

• Total Fluoroscopy Time

  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

  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)

  Estimated intraoperative blood loss, compared between labrum excision and labrum preservation groups.

  Intraoperative (at time of surgery)

Secondary Outcomes (9)

• Iliopsoas Pain

  Within 90 days postoperatively

• Instability

  90 days and 1 year postoperatively

• Dislocation

  90 days and 1 year postoperatively

• Periprosthetic Joint Infection (PJI)

  90 days and 1 year postoperatively

• Reoperation

  90 days and 1 year postoperatively

Study Arms (2)

Group A: Labrum Excision

ACTIVE COMPARATOR

This group has their labrum excised, with is the standard of care for THA.

Procedure: Labrum Excision

Group B: Labrum Preservation

EXPERIMENTAL

The experimental group to test recovery outcomes from preserving the labrum.

Procedure: Labrum Preservation

Interventions

Labrum Preservation PROCEDURE

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.

Group B: Labrum Preservation

Labrum Excision PROCEDURE

The acetabular labrum will be removed during surgery, prior to final cup placement.

Group A: Labrum Excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Total Joint Specialists: lead

Study Sites (1)

Total Joint Surgery Center Atlanta

Sandy Springs, Georgia, 30328, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: September 10, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

US (1)