Hip Arthroscopy Improves Muscle Volumes in Patients With... | NCT04946513

Studies
Hip Arthroscopy Improves Muscle Volumes in Patients With Femoroacetabular Impingement Syndrome

NCT04946513

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 1, 2021Actual

Enrollment

195Actual

Phase

Not provided

Conditions

Femoroacetabular Impingement Syndrome

Interventions

Muscle volumes were measured on pre- and postoperative MRI scans.

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Mar 1, 2020Actual

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jun 27, 2021

First Posted Date

Jul 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2021

Last Update Posted Date

Jul 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To explore the changes of the muscles around the hip joint after hip arthroscopy for patients with femoral acetabular impingement syndrome.

Detailed Description

Retrospectively investigate the influence of hip arthroscopy on the muscle volume around the hip joint, and to provide important information for clinicians to make diagnosis and treatment plan of hip joint disease.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

195Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients with femoroacetabular impingement syndrome and underwent hip arthroscopy。	Other: Muscle volumes were measured on pre- and postoperative MRI scans.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Muscle volumes were measured on pre- and postoperative MRI scans.	Other	Muscle volumes were measured on pre- and postoperative MRI scans.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle volumes	Difference between pre- and postoperative muscle volumes	1 year after hip arthroscopy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: (1) Age 18-50 years old; (2) Diagnosed femoroacetabular impingement syndrome; (3) Conservative treatment ineffective; (4) complete preoperative and postoperative MRI images; -

Exclusion Criteria: (1) bilateral; (2) revision; (3) osteoarthritis; (4) acetabular dysplasia; (5) history of hip and knee joint disease or surgery; (6) femoral head necrosis; (7) sacroiliac joint disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Patients with femoroacetabular impingement syndrome and underwent hip arthroscopy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jian-quan Wang, M.D.	Peking University Third Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057925	Femoracetabular Impingement

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided