NCT04983992

Brief Summary

The study of July 2021 to July 2022 to undergraduate course to see a doctor and accept the lateral retinaculum capsule of external release the prospectie study of 100 patients with follow-up, compared with preoperative and postoperative imaging data, clinical manifestations, signs, etc., to evaluate the surgical effect, at the same time of resection specimens for pathology and genetics research,To investigate the pathogenesis of lateral patella compression syndrome.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

10 months

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)

  • Pain severity change

    2years

  • Clinical symptom change

    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 releases the lateral retinaculum from outside the knee capsular, maintaining the structure of the knee capsular.

observation group

Eligibility Criteria

Age10 Years - 40 Years
Sexall
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 strength line of lower limbs: no valgus or varus feet (HKA \<±5°)

You may not qualify if:

  • Combined patella dislocation and medial retinacular injury.
  • Have a history of knee surgery, knee injury and fracture.
  • Complicated cruciate ligament injury and medial and lateral collateral ligament injury.
  • Combined knee osteoarthritis.
  • Complicated with rheumatism, rheumatoid arthritis and other types of arthritis
  • Patellar bisection, trochlear dysplasia
  • Gouty arthritis and hyperuricemia of the knee
  • Complicated meniscus injury of degree III or above
  • Incorporating lateral discoid meniscus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

lateral retinaculum of the knee

Study Design

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

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 30, 2021

Study Start

September 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2024

Last Updated

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share