Total Hip Arthroplasty (THA)NCT07812025
Comparing Outcomes of Labrum Preservation vs Excision in Primary Total Hip Arthroplasty
A study testing Labrum Preservation and Labrum Excision in people with Total Hip Arthroplasty (THA), run by Total Joint Specialists at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Labrum Preservation and Labrum Excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Total Joint Surgery Center Atlanta
Sandy Springs, Georgia, 30328
About this study
Official title: 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.
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- Labrum Preservation, Labrum Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labrum PreservationProcedure or surgery
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 ExcisionProcedure or surgery
The acetabular labrum will be removed during surgery, prior to final cup placement.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Labrum Excision | Active comparator | This group has their labrum excised, with is the standard of care for THA. Receives: Procedure: Labrum Excision |
| Group B: Labrum Preservation | Experimental | The experimental group to test recovery outcomes from preserving the labrum. Receives: Procedure: Labrum Preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraoperative (at time of surgery)
Total Fluoroscopy Time
Total fluoroscopy time recorded during the surgical procedure, compared between labrum excision and labrum preservation groups.
Measured: 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.
Measured: Intraoperative (at time of surgery)
Estimated Blood Loss (EBL)
Estimated intraoperative blood loss, compared between labrum excision and labrum preservation groups.
Measured: Intraoperative (at time of surgery)
Secondary outcomes (9)
Iliopsoas Pain
Incidence of iliopsoas pain reported within 90 days after surgery, compared between labrum excision and labrum preservation groups.
Measured: Within 90 days postoperatively
Instability
Incidence of postoperative hip instability, compared between labrum excision and labrum preservation groups.
Measured: 90 days and 1 year postoperatively
Dislocation
Incidence of postoperative hip dislocation, compared between labrum excision and labrum preservation groups.
Measured: 90 days and 1 year postoperatively
Periprosthetic Joint Infection (PJI)
Incidence of periprosthetic joint infection, compared between labrum excision and labrum preservation groups.
Measured: 90 days and 1 year postoperatively
Reoperation
Incidence of reoperation for any cause, compared between labrum excision and labrum preservation groups.
Measured: 90 days and 1 year postoperatively
All-Cause Revision
Incidence of revision surgery for any cause, compared between labrum excision and labrum preservation groups.
Measured: 90 days and 1 year postoperatively
Wound Complications
Incidence of postoperative wound complications, compared between labrum excision and labrum preservation groups.
Measured: 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.
Measured: 90 days and 1 year postoperatively
Readmission
Incidence of hospital readmission, compared between labrum excision and labrum preservation groups.
Measured: 90 days and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start7 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Total Joint Specialists
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812025
- Sponsor's protocol ID
- NSH1444
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided