NCT04992806

Brief Summary

To study the effect of arthroscopy on the treatment of hip diseases and to evaluate the regularity and treatment of hip joint diseases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 5, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 27, 2021

Last Update Submit

July 29, 2021

Conditions

Femoroacetabular ImpingementAcetabular Labral Tear

Outcome Measures

Primary Outcomes (3)

  • The patient was followed up at 1 year after surgery to evaluate the Visual Analog Scale (VAS).

    Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.

    1 year after operation

  • The patient was followed up at 2 years after surgery to evaluate the Visual Analog Scale (VAS).

    Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.

    2 years after operation

  • The patient was followed up at 5 years after surgery to evaluate the Visual Analog Scale (VAS).

    Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.

    5 years after operation

Secondary Outcomes (6)

  • The patient was followed up at 1 year after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).

    1 year after operation

  • The patient was followed up at 2 years after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).

    2 years after operation

  • The patient was followed up at 5 years after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).

    5 years after operation

  • The patient was followed up at 1 year after surgery to evaluate modified Harris Hip Score (mHHS).

    1 year after operation

  • The patient was followed up at 2 years after surgery to evaluate modified Harris Hip Score (mHHS).

    2 years after operation

  • +1 more secondary outcomes

Study Arms (1)

patients accepted hip arthroscopy

patients with hip diseases and accepted hip arthroscopy in Peking University Third Hospital

Procedure: hip arthroscopy

Interventions

hip arthroscopyPROCEDURE

Use epidural anesthesia or general anesthesia. The patient lies on the orthopedic traction bed to protect the perineum and perform traction of the lower limbs on the surgical side. Under arthroscopy, check the labrum, acetabular articular surface and femoral head cartilage, and round ligament in turn. The acetabular labrum with tear degeneration was treated with labrum suture or labrum revision surgery according to the injury. Perform femoral head and neck plastic or acetabular plastic surgery, osteoid osteoma debridement, etc.

patients accepted hip arthroscopy

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We evaluated consecutive patients who were diagnosed with hip diseases (i.e. FAI, Acetabulum labrum tear) and who underwent hip arthroscopy at our hospital between January 2011 and January 2016.

You may qualify if:

  • The patient received imaging examination before surgery and was diagnosed with hip joint labrum injury, FAI and other hip joint diseases, and the patient complained of pain in the hip joint, buttocks or thigh. Conservative treatment is ineffective for more than 6 months.

You may not qualify if:

  • History of hip surgery, hip osteoarthritis, femoral head necrosis, hip infection, rheumatic disease, lumbar disease, ankylosing spondylitis, or sacroiliac joint disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100083, China

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • yan xu

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 27, 2021

First Posted

August 5, 2021

Study Start

June 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

August 5, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)