NCT05998720

Brief Summary

Explore the imaging and quantitative monitoring of hip bone, cartilage and ligament by magnetic resonance UTE technology, combined with QCT and DXA technology, to provide a more accurate basis for clinical evaluation and treatment.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

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

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2024

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

August 2, 2023

Last Update Submit

August 17, 2023

Conditions

Hip Disease

Outcome Measures

Primary Outcomes (4)

  • proton density fat fraction (PDFF)

    Magnetic resonance proton density fat fraction

    Baseline (before surgery)

  • T2 relaxation rate

    R2\*

    Baseline (before surgery)

  • Magnetization Transfer Ratio (MTR)

    magnetization transfer ratio

    Baseline (before surgery)

  • T1rho

    spin-lattice relaxation in the rotation ame

    Baseline (before surgery)

Secondary Outcomes (1)

  • Subjective rating values

    Baseline (before surgery)

Study Arms (2)

normal group

There are no lesions on the hip.

abnormal group

There are some lesions on the hip.

Eligibility Criteria

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

Patients who meet the inclusion criteria

You may qualify if:

  • Patients with past or suspected osteoporosis and bone loss;
  • Patients with previous femoral neck fracture;
  • Patients with avascular necrosis of femoral head;
  • Hip osteoarthritis patients.

You may not qualify if:

  • Patients with metal implants in corresponding parts;
  • Claustrophobic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiography department

Zhuhai, Guangdong, 519000, China

RECRUITING

Study Officials

  • Shaolin Li

    Fifth Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Xiaojun Chen

CONTACT

+8615820587112422175400@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 21, 2023

Study Start

July 1, 2023

Primary Completion

June 13, 2024

Study Completion

June 13, 2024

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)