Difference of Plantar Pressure Distribution Between Surgi... | NCT04961892

Studies
Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for CAI

NCT04961892

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 14, 2021Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Chronic Ankle Instability

Interventions

surgical treatment
conservative treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

Jun 25, 2021

First Submission Date that Met QC Criteria

Jul 4, 2021

First Posted Date

Jul 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2021

Last Update Posted Date

Jul 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The data of 20 patients who underwent surgery after reconstruction of the lateral collateral ligament of the ankle joint and 20 patients who underwent balance rehabilitation training were analyzed to compare the clinical effects of surgical treatment and conservative treatment for chronic ankle instability, in order to better guide the selection of the optimal intervention program for patients with chronic ankle joint.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgical treatment		Patients with CAI undergoing surgical treatment	Procedure: surgical treatment
conservative treatment		Patients with CAI undergoing conservative treatment	Procedure: conservative treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgical treatment	Procedure	Anatomical contraction and termination reconstruction of the lateral ligament	surgical treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FAAM	Foot and Ankle Ability Measure Activity	pre-surgery, one year after sugery

Secondary Outcomes

Measure	Description	Time Frame
IDFAI	Identification of Functional Ankle Instability questionnaire	pre-surgery, one year after sugery
Ligament injury by MRI	To evaluate the condition of lateral collateral ligament using magnetic resonance imaging

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with CAI
The contralateral ankle joint is healthy

Exclusion Criteria:

Accompanied by other musculoskeletal injuries

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuelin Hu, bachelor	Peking University Third Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative
D000072700	Conservative Treatment

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided