NCT04977492

Brief Summary

This research focuses on 1 January 2015 to December 2018 to the undergraduate course to see a doctor and accept the lateral retinaculum extracapsular release of 100 patients were retrospectively study, through the follow-up, compare the preoperative and postoperative radiographic data, clinical manifestations, signs, etc., to evaluate the surgical effect and explore the pathogenesis of patellar lateral compression syndrome.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

4 years

First QC Date

June 27, 2021

Last Update Submit

July 25, 2021

Conditions

Keywords

excessive lateral pressure syndromepatellofemoral jointtibiofemoral joint

Outcome Measures

Primary Outcomes (1)

  • Change of lesions

    The improvement of cartilage injury of patellofemoral joint and tibiofemoral joint. Two senior surgeons read the MRI separately, recording the status of lesion area. The lesion area was compared before and after surgery. Using Outerbridge Classification to evaluate the severity of cartilage injury.

    2years

Secondary Outcomes (2)

  • Clinical symptom change

    2years

  • Pain severity

    2years

Study Arms (2)

observation group

People suffered from excessive lateral pressure syndrome with extracapsular release of lateral retinaculum.

Procedure: extracapsular release of lateral retinaculum

control group

People suffered from excessive lateral pressure syndrome with conservative treatment.

Interventions

A new kind of surgery which releases the lateral retinaculum from outside the knee capsular, maintaining the structure of the knee capsular.

observation group

Eligibility Criteria

AgeUp to 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Young and middle-aged sports active people

You may qualify if:

  • Age \<40.
  • Normal lower limb strength line: no valgus or varus feet, no hyperpronation of hind feet, negative J sign.

You may not qualify if:

  • Combined patella instability and patella dislocation.
  • Have a history of knee surgery and knee fracture.
  • Complicated cruciate ligament injury and medial and lateral collateral ligament injury.
  • Osteoarthritis of the knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 27, 2021

Study Start

January 1, 2015

Primary Completion

December 31, 2018

Study Completion

June 1, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share