A Retrospective Study on the Effect of Surgery on Hip Diseases

July 29, 2021 updated by: Peking University Third Hospital

A Retrospective Study on the Effect of Arthroscopy on Hip Diseases

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To study the clinical effect of arthroscopic treatment in patients with hip disease, a retrospective study was conducted on 600 patients with hip disease from January 2011 to January 2016. All patients underwent preoperative examinations. These included preoperative supine anteroposterior hip radiographs, cross-lateral radiographs, computed tomography (CT), and magnetic resonance imaging.Preoperative patient-reported outcomes (PROs), including visual analogue scale (VAS), international hip prognostic instrument-12 (IHOT-12), and modified Harris hip score (MHHS), were evaluated at 1, 2, and 5 years after surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100083
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients accepted hip arthroscopy
patients with hip diseases and accepted hip arthroscopy in Peking University Third Hospital
Procedure: hip arthroscopy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The patient was followed up at 1 year after surgery to evaluate the Visual Analog Scale (VAS).
Time Frame: 1 year after operation
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).
Time Frame: 2 years after operation
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).
Time Frame: 5 years after operation
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The patient was followed up at 1 year after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).
Time Frame: 1 year after operation
The International Hip Outcome Tool-12 (iHOT-12).The highest score was 120, and the lowest was 0. The higher the score, the better the postoperative recovery.
1 year after operation
The patient was followed up at 2 years after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).
Time Frame: 2 years after operation
The International Hip Outcome Tool-12 (iHOT-12).The highest score was 120, and the lowest was 0. The higher the score, the better the postoperative recovery.
2 years after operation
The patient was followed up at 5 years after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).
Time Frame: 5 years after operation
The International Hip Outcome Tool-12 (iHOT-12).The highest score was 120, and the lowest was 0. The higher the score, the better the postoperative recovery.
5 years after operation
The patient was followed up at 1 year after surgery to evaluate modified Harris Hip Score (mHHS).
Time Frame: 1 year after operation
Modified Harris Hip Score (mHHS).The highest score was 44, and the lowest was 0. The higher the score, the better the postoperative recovery.
1 year after operation
The patient was followed up at 2 years after surgery to evaluate modified Harris Hip Score (mHHS).
Time Frame: 2 years after operation
Modified Harris Hip Score (mHHS).The highest score was 44, and the lowest was 0. The higher the score, the better the postoperative recovery.
2 years after operation
The patient was followed up at 5 years after surgery to evaluate modified Harris Hip Score (mHHS).
Time Frame: 5 years after operation
Modified Harris Hip Score (mHHS).The highest score was 44, and the lowest was 0. The higher the score, the better the postoperative recovery.
5 years after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: yan xu, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00006761-2016015

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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