NCT04454021

Brief Summary

The purpose of this study was to investigate the change in muscle volume around the hip in patients with unilateral femoro-acetabular impingement (FAI) after arthroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 28, 2020

Last Update Submit

June 30, 2020

Conditions

Femoro-acetabular Impingement (FAI)

Keywords

femoro-acetabular impingementhip muscle volumecross-sectional areaarthroscopyMRI images

Outcome Measures

Primary Outcomes (1)

  • Change in muscle volume after hip arthroscopy

    hip muscle cross-sectional area of patients with unilateral FAI

    at least two years after hip arthroscopy

Interventions

hip arthroscopyPROCEDURE

hip arthroscopy was performed when symptoms were not alleviated by nonsurgical treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent primary hip arthroscopy for the treatment of symptomatic FAI

You may qualify if:

  • (1) Age 18-50 years; (2) symptoms, physical examination, imaging evidence in accordance with FAI; (3) symptoms that were not alleviated by nonsurgical treatment; (4) the operation is performed by the same senior operator.

You may not qualify if:

  • (1) bilateral symptoms; (2) revision surgery; (3) advanced osteoarthritis; (4) acetabular dysplasia; (5) history of hip and knee joint disease and operation; (6) osteonecrosis of hip; (7) sacroiliac joint disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianquan Wang

Beijing, Haidian District, 100191, China

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 1, 2020

Study Start

January 10, 2020

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)