NCT05720806

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

January 10, 2023

Last Update Submit

September 16, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • International Hip Outcome Tool 12 (iHot-12)

    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

    up to 6 months post-operative

  • Hip and Groin Outcome Score (HAGOS)

    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

    up to 6 months post-operative

  • Hip Outcome Score (HOS) ADL

    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.

    up to 6 months post-operative

  • Hip Outcome Score (HOS) Sport

    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.

    up to 6 months post-operative

  • Tampa Scale for Kinesiophobia-11

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

    up to 6 months post-operative

Secondary Outcomes (4)

  • Isometric strength measures hip add, abd, ER, and extension

    6-week, 3 months, and 6-month post-operative

  • Diagnostic ultrasound assessment of bilateral anterior hip capsule thickness

    3 months post-operative

  • Diagnostic ultrasound assessment of incision widening

    3 months post-operative

  • Diagnostic ultrasound for focal echogenic adhesions

    3 months post-operative

Study Arms (2)

Weight bearing as tolerated (WBAT) immediately following surgery.

EXPERIMENTAL

Subjects will be able to self-select weight bearing based on pain and confidence in surgical hip.

Other: Weight Bearing as tolerated (WBAT) immediately following surgery.

Flat foot weight bearing (FFWB) for 2 weeks after surgery.

ACTIVE COMPARATOR

Subjects will be limited to FFWB, approx 20lbs through the surgical hip.

Other: Flat foot weight bearing (FFWB) immediately following surgery

Interventions

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.

Weight bearing as tolerated (WBAT) immediately following surgery.

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

Flat foot weight bearing (FFWB) for 2 weeks after surgery.

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Hip Preservation Program

Pittsburgh, Pennsylvania, 15238, United States

Location

MeSH Terms

Interventions

Weight-Bearing

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Physician performing surgical intervention will be blinded from surgery until first follow up. Also, physician performing ultrasound evaluation of hip capsule will remain blinded to weight bearing designation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects will be enrolled into either Weight bearing as tolerated group immediately or Flat foot weight bearing group for 2 weeks. Currently, flat foot weight bearing for the first 2 weeks is standard of care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 9, 2023

Study Start

May 1, 2023

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations