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Completed

NCT Number: NCT05720806

Weight Bearing Status Post-hip Arthroscopy

This study is being proposed to examine weight bearing precautions following hip arthroscopic labral repair, femoroplasty, and capsular closure. Standard post operative protocols limit weight bearing for 2-6 weeks depending on individual surgeons. Cadaveric studies demonstrate that minimal force during weight bearing is distributed through labrum. Therefore, progressing weight bearing earlier in these patients post operatively may help progress faster and improve outcomes. Data collected will include demographic information, radiological data, operative procedures and PRO data.

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Key information

Conditions

Hip Impingement Syndrome Acetabular Labral Tear

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Hip Preservation Program

Pittsburgh, Pennsylvania, 15238, United States

About this study

The study will be conducted at UPMC St. Margaret's Hip Preservation Program. Consented patients who undergo acetabular labral repair and femoroplasty will be included in randomization of weight-bearing status. Two separate protocols will be created to indicate weight bearing status, either WBAT immediately post-op or FFWB immediately post-op, to distribute to rehabilitation staff to ensure compliance. Immediately after the surgical procedure, the surgeon will be blinded and a randomized pamphlet with post-operative instructions with weight bearing education will be given to PACU nursing staff to educate patients and fit crutches.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age>= 12 years
  • Diagnoses: femoroacetabular impingement and hip labral tears.
  • Surgical procedures performed: Hip arthroscopy with femoroplasty and labral repair.
  • Surgery completed at UPMC Children's or UPMC St. Margaret's Hospital
  • unilateral and bilateral hip patients

Exclusion criteria

  • MSK tumor-related FAI or dysplasia
  • generalized hypermobility
  • revision surgeries

Treatment and study plan

Weight Bearing as tolerated (WBAT) immediately following surgery.

Other

Subject will be provided standard of care physical therapy following surgical intervention, except will be able to self-select weight bearing based on pain and confidence.

Flat foot weight bearing (FFWB) immediately following surgery

Other

Subject will be provided standard of care physcial therapy following surgical intervention except

Primary outcomes

  1. International Hip Outcome Tool 12 (iHot-12)

    Time frame: up to 6 months post-operative

    Scoring ranges from 0-100

    • each question is rated from 0-100 and final score is the mean of all questions answered by subject
    • higher scoring indicating higher quality of life due to hip function

  2. Hip and Groin Outcome Score (HAGOS)

    Time frame: up to 6 months post-operative

    This outcome includes 6 subscales, these are scored independently, and no aggregate scoring is calculated as each section assesses different dimensions separately.

    Subscales (raw scores for each subscale converted to a 0-100 scale with higher score indicating higher level of function):

    • Pain
    • Symptoms
    • Activities of Daily Life
    • Function in Sport and recreation
    • Participation in Physical Activities
    • hip and groin-related quality of life

  3. Hip Outcome Score (HOS) ADL

    Time frame: up to 6 months post-operative

    Outcome assessing function with activities of daily living. Higher score is given for higher level of function and lower score indicating reduced function.

    0-68 aggregate scoring converted to 0-100 scale.

  4. Hip Outcome Score (HOS) Sport

    Time frame: up to 6 months post-operative

    Outcome assessing function/difficulty completing dynamic activities associated with sports participation. Higher score is given for higher level of function and lower score indicating reduced function.

    0-36 aggregate scoring converted to 0-100 scale.

  5. Tampa Scale for Kinesiophobia-11

    Time frame: up to 6 months post-operative

    Outcome measure assessing fear of pain with movement. Scores range from 11 to 44. Higher scores indicate greater fear of movement

Secondary outcomes

  1. Isometric strength measures hip add, abd, ER, and extension

    Time frame: 6-week, 3 months, and 6-month post-operative

    Strength measures will be taken isometrically at post-operative follow ups.

  2. Diagnostic ultrasound assessment of bilateral anterior hip capsule thickness

    Time frame: 3 months post-operative

    Physician while blinded will perform ultrasound evaluation of the hip capsule to ensure healing.

    Ultrasound will measure the following:

    1.Assess the bilateral hip anterior capsule in all patients, assessing for internal consistency or changes in capsular thickness from side to side. Normal hip capsular thickness has been reported as 7-8 mm, dysplastic hips range 3.2 +/- 0.5 mm, and femoroacetabular impingement subjects 4.7 +/- 0.6 mm.

  3. Diagnostic ultrasound assessment of incision widening

    Time frame: 3 months post-operative

    Physician while blinded will perform ultrasound evaluation of the hip capsule to ensure healing.

    • Evaluation of capsular incision widening, cyst, attenuation and thinning from established norms. Normal hip capsular thickness has been reported as 7-8 mm, dysplastic hips range 3.2 +/- 0.5 mm, and femoroacetabular impingement subjects 4.7 +/- 0.6 mm

  4. Diagnostic ultrasound for focal echogenic adhesions

    Time frame: 3 months post-operative

    Physician while blinded will perform ultrasound evaluation of the hip capsule to ensure healing.

    • Evaluate for focal echogenic adhesions or dyskinetic motion between capsule and overlying iliopsoas complex with activation of hip flexion.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Weight Bearing as Tolerated (WBAT) Following Hip Arthroscopic Labral Repair and Femoroplasty.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 9, 2023
Registry last updated
May 13, 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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