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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Total Hip Arthroplasty (THA)
• Intervention / Treatment: Procedure: Labrum Excision; Procedure: Labrum Preservation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Total Joint Surgery Center Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Labrum Excision; This group has their labrum excised, with is the standard of care for THA.	Procedure: Labrum Excision; The acetabular labrum will be removed during surgery, prior to final cup placement.
Experimental: Group B: Labrum Preservation; The experimental group to test recovery outcomes from preserving the labrum.	Procedure: Labrum 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iliopsoas Pain	Incidence of iliopsoas pain reported within 90 days after surgery, compared between labrum excision and labrum preservation groups.	Within 90 days postoperatively
Instability	Incidence of postoperative hip instability, compared between labrum excision and labrum preservation groups.	90 days and 1 year postoperatively
Dislocation	Incidence of postoperative hip dislocation, compared between labrum excision and labrum preservation groups.	90 days and 1 year postoperatively
Periprosthetic Joint Infection (PJI)	Incidence of periprosthetic joint infection, compared between labrum excision and labrum preservation groups.	90 days and 1 year postoperatively
Reoperation	Incidence of reoperation for any cause, compared between labrum excision and labrum preservation groups.	90 days and 1 year postoperatively
All-Cause Revision	Incidence of revision surgery for any cause, compared between labrum excision and labrum preservation groups.	90 days and 1 year postoperatively
Wound Complications	Incidence of postoperative wound complications, compared between labrum excision and labrum preservation groups.	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.	90 days and 1 year postoperatively
Readmission	Incidence of hospital readmission, compared between labrum excision and labrum preservation groups.	90 days and 1 year postoperatively

Collaborators and Investigators

• Sponsor: Total Joint Specialists

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NSH1444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No