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OpenTrials
Enrolling by invitation

NCT Number: NCT07812025

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

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.

Enrolling by invitation

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Key information

Conditions

Total Hip Arthroplasty (THA)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Total Joint Surgery Center Atlanta

Sandy Springs, Georgia, 30328, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Labrum Excision

Procedure

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

Primary outcomes

  1. Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS)

    Time frame: 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.

  2. Veterans RAND 12-Item Health Survey (VR-12) Mental Component Score (MCS)

    Time frame: 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.

  3. Procedure Satisfaction (5-Point Likert Scale)

    Time frame: 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.

  4. Numeric Pain Rating Scale (NPRS)

    Time frame: 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.

  5. HOOS, JR. (Hip Disability and Osteoarthritis Outcome Score for Joint Replacement)

    Time frame: 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.

  6. Forgotten Joint Score-12 (FJS-12)

    Time frame: 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.

  7. Intraoperative Soft-Tissue/Labral Interference with Cup Position

    Time frame: 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.

  8. Protocol Deviation Rate (Labral Removal in Preservation Arm)

    Time frame: 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.

  9. Operative Time

    Time frame: 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.

  10. Total Fluoroscopy Time

    Time frame: Intraoperative (at time of surgery)

    Total fluoroscopy time recorded during the surgical procedure, compared between labrum excision and labrum preservation groups.

  11. Incidence of Supplemental Acetabular Screw Use

    Time frame: Intraoperative (at time of surgery)

    Proportion of patients requiring supplemental acetabular screws for component fixation, compared between labrum excision and labrum preservation groups.

  12. Estimated Blood Loss (EBL)

    Time frame: Intraoperative (at time of surgery)

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

Secondary outcomes

  1. Iliopsoas Pain

    Time frame: Within 90 days postoperatively

    Incidence of iliopsoas pain reported within 90 days after surgery, compared between labrum excision and labrum preservation groups.

  2. Instability

    Time frame: 90 days and 1 year postoperatively

    Incidence of postoperative hip instability, compared between labrum excision and labrum preservation groups.

  3. Dislocation

    Time frame: 90 days and 1 year postoperatively

    Incidence of postoperative hip dislocation, compared between labrum excision and labrum preservation groups.

  4. Periprosthetic Joint Infection (PJI)

    Time frame: 90 days and 1 year postoperatively

    Incidence of periprosthetic joint infection, compared between labrum excision and labrum preservation groups.

  5. Reoperation

    Time frame: 90 days and 1 year postoperatively

    Incidence of reoperation for any cause, compared between labrum excision and labrum preservation groups.

  6. All-Cause Revision

    Time frame: 90 days and 1 year postoperatively

    Incidence of revision surgery for any cause, compared between labrum excision and labrum preservation groups.

  7. Wound Complications

    Time frame: 90 days and 1 year postoperatively

    Incidence of postoperative wound complications, compared between labrum excision and labrum preservation groups.

  8. Venous Thromboembolism (DVT/PE)

    Time frame: 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.

  9. Readmission

    Time frame: 90 days and 1 year postoperatively

    Incidence of hospital readmission, compared between labrum excision and labrum preservation groups.

Interested in participating?

Enrolling by invitation

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Total Joint Specialists

Network

Registry information

Official study title

Labral Excision vs Preservation in Primary Total Hip Arthroplasty: A Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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