Weight Bearing Status Post-hip Arthroscopy

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acetabular Labral Tear; Hip Impingement Syndrome
• Intervention / Treatment: Other: Weight Bearing as tolerated (WBAT) immediately following surgery.; Other: Flat foot weight bearing (FFWB) immediately following surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15238
      • UPMC Hip Preservation Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weight bearing as tolerated (WBAT) immediately following surgery.; 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.; 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.
Active Comparator: Flat foot weight bearing (FFWB) for 2 weeks after surgery.; Subjects will be limited to FFWB, approx 20lbs through the surgical hip.	Other: Flat foot weight bearing (FFWB) immediately following surgery; Subject will be provided standard of care physcial therapy following surgical intervention except

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric strength measures hip add, abd, ER, and extension	Strength measures will be taken isometrically at post-operative follow ups.	6-week, 3 months, and 6-month post-operative
Diagnostic ultrasound assessment of bilateral anterior hip capsule thickness	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 months post-operative
Diagnostic ultrasound assessment of incision widening	Physician while blinded will perform ultrasound evaluation of the hip capsule to ensure healing. 1. 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	3 months post-operative
Diagnostic ultrasound for focal echogenic adhesions	Physician while blinded will perform ultrasound evaluation of the hip capsule to ensure healing. 1. Evaluate for focal echogenic adhesions or dyskinetic motion between capsule and overlying iliopsoas complex with activation of hip flexion.	3 months post-operative

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): July 28, 2025

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY22080053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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