The Clinical Effect of Different Lateral Retinaculum Rela... | NCT04958603

Studies
The Clinical Effect of Different Lateral Retinaculum Relaxation Methods in the Treatment of LPCS

NCT04958603

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 12, 2021Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Lateral Patellar Compression Syndrome

Interventions

"L" type release surgery

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, 2020Actual

Primary Completion Date

May 1, 2020Actual

Completion Date

Nov 1, 2020Actual

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 12, 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 8, 2021

Last Update Posted Date

Jul 12, 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

To observe the comparison of the clinical effects of two different ways of loosening the lateral support band under arthroscopy to treat lateral patella excessive compression syndrome.

Detailed Description

To analyze the surgical conditions of 64 patients with lateral patella excessive compression syndrome who were surgically treated by Deputy Chief Physician Yang Yuping of the Department of Sports Medicine, Peking University Third Hospital from September 2004 to January 2019. Among them, 24 early cases used the traditional proximal release of the lateral retinaculum (traditional surgical group), and recently 40 cases, after learning from the surgical experience of the early cases, switched to the lateral release of the lateral retinaculum, that is, "L" type Release (new surgery group). The visual analog scale (VAS), Lysholm score, and IKDC knee function subjective evaluation scale (IKDC) score were performed before and after the operation. By analyzing the knee movement scores of patients before and after surgery, the efficacy of the above two operations was judged, and the two groups of postoperative scores were evaluated.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Traditional surgery group		Traditionally loosen the lateral support belt proximally
New surgery group		Laterally loosen the outer support belt, that is, "L"-shaped loosen	Procedure: "L" type release surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
"L" type release surgery	Procedure	Lateral release of the lateral support belt	New surgery group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analogue scale (VAS)	VAS is used to evaluate knee function. The higher the score of VAS, the better the recovery of knee function	Six months after surgery
(International Knee Documentation Committee) IKDC knee function subjective evaluation form score	IKDC score is used to evaluate knee function. The higher the score of IKDC score, the better the recovery of knee function	Six months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

From September 2004 to January 2019, patients with lateral patella overcrowding syndrome treated by deputy chief physician Yang Yuping of the Department of Sports Medicine, Peking University Third Hospital

Exclusion Criteria:

From September 2004 to January 2019, patients with lateral patella overcrowding syndrome treated by deputy chief physician Yang Yuping of the Department of Sports Medicine, Peking University Third Hospital

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 September 2004 to January 2019, patients with lateral patella overcrowding syndrome treated by deputy chief physician Yang Yuping of the Department of Sports Medicine, Peking University Third Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
yuping yang	Peking University Third Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Univerisity Third Hospital		Beijing	Beijing Municipality	100191	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