Clinical Outcome of Arthroscopic Lateral Release for Late... | NCT04313556

Studies
Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome

NCT04313556

Sponsor

Hawler Medical University

Status

Completed

Last Update Posted

Mar 18, 2020Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Knee Pain Chronic

Interventions

Lateral patellar release

Countries

Not provided

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

Mar 2020

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

Dec 4, 2016Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Aug 30, 2019Actual

First Submitted Date

Mar 16, 2020

First Submission Date that Met QC Criteria

Mar 17, 2020

First Posted Date

Mar 18, 2020Actual

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

Mar 17, 2020

Last Update Posted Date

Mar 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherwan Ahmed Ali Hamawandi, Assistant professor of orthopedic surgery, Hawler Medical UniversityPrincipal Investigator

Lead Sponsor

Hawler Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

We performed a prospective case series study of 48 patients who suffered Lateral patellar compression syndrome who were diagnosed by clinical examination and confirmed by M.R.I. and failed conservative management and underwent isolated arthroscopic lateral patellar retinaculum release in Erbil Teaching Hospital, PAR Private Hospital and Hawler Private Hospital between December 2016 and August 2019.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lateral patellar release	Other	Arthroscopic lateral patellar retinacular release	Procedure: Lateral patellar release

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lateral patellar release	Procedure	Arthroscopic lateral patellar reticular release	Lateral patellar release

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lysholm Knee Score	Eight sections are assessed to produce an overall score on a scale of 0 to 100. Then an assignment is given as "excellent" for 95 to 100 points; "good" for 85 to 94 points, "fair" for 65 to 84 points, or "poor" for less than 65 points	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lateral patellar compression syndrome proved by clinical,MRI and Arthroscopic examination

Exclusion Criteria:

Dislocated or history of dislocation.
Patellar instability.
Bony abnormality (trochlear groove hypoplasia or flat).
Osteoarthritis of the knee 3rd and 4th grades.
Infected knee.
Varus and valgus knee.
Rotational deformity of the lower extremity.
Miserable malalignment triad.
Anterior cruciate ligament, posterior cruciate ligament and medial collateral ligament rupture.
History of fracture around knee.
Focal Osteoarthritis of the lateral facet joint.
Chondral lesion (Outerbridge 3 and 4).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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