NCT06972914

Brief Summary

To evaluate the correlation between wearing time of different braces and short-term functional changes such as knee functional score, knee circumference and postoperative recovery Angle after ACL reconstruction, and provide preliminary evidence and key data for subsequent research on whether and how long it is necessary to wear braces after ACL reconstruction.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

January 6, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

May 15, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

April 29, 2025

Last Update Submit

May 14, 2025

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation

Keywords

Anterior cruciate ligament reconstructionrehabilitationbrace

Outcome Measures

Primary Outcomes (2)

  • Thigh circumference

    Thigh dimension: centimeters(cm)

    Preoperative, postoperative 3 weeks, 6 weeks, 3 months, 6 months, 9 months

  • Degree of Joint range of motion

    Degree of Joint range of motion

    Preoperative, postoperative 3 weeks, 6 weeks, 3 months, 6 months, 9 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after anterior cruciate ligament reconstruction

You may qualify if:

  • Patients with acute anterior cruciate ligament injury undergoing anterior cruciate ligament reconstruction

You may not qualify if:

  • Refused to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital of Chongli

Chongli, Hebei, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Age, sex, time of onset, diagnosis, underlying disease, complications, perioperative status, knee circumference, Lysholm score, IKDC score, muscle strength, graft maturity

Study Design

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

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 15, 2025

Study Start

January 6, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

May 15, 2025

Record last verified: 2025-01

Locations

CN(1)