NCT04961892

Brief Summary

The objective of this study was to compare the difference of plantar pressure distribution between surgical treatment and conservative treatment for CAI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
Last Updated

July 14, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 25, 2021

Last Update Submit

July 4, 2021

Conditions

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (1)

  • FAAM

    Foot and Ankle Ability Measure Activity

    pre-surgery, one year after sugery

Secondary Outcomes (2)

  • IDFAI

    pre-surgery, one year after sugery

  • Ligament injury by MRI

    pre-surgery, one year after sugery

Study Arms (2)

surgical treatment

Patients with CAI undergoing surgical treatment

Procedure: surgical treatment

conservative treatment

Patients with CAI undergoing conservative treatment

Procedure: conservative treatment

Interventions

surgical treatmentPROCEDURE

Anatomical contraction and termination reconstruction of the lateral ligament

surgical treatment
conservative treatmentPROCEDURE

Rehabilitation intervention training

conservative treatment

Eligibility Criteria

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

From April 1, 2019, information of 20 patients diagnosed with CAI that underwent surgical treatment in our institute and 20 patients that underwent conservative treatment was collected and evaluated.

You may qualify if:

  • Patients diagnosed with CAI
  • The contralateral ankle joint is healthy

You may not qualify if:

  • Accompanied by other musculoskeletal injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Interventions

Surgical Procedures, OperativeConservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Yuelin Hu, bachelor

    Peking University Third Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 14, 2021

Study Start

April 1, 2019

Primary Completion

April 1, 2020

Study Completion

June 1, 2020

Last Updated

July 14, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)