Open Versus Arthroscopic Release for Lateral Patellar Com... | NCT04130412

Studies
Open Versus Arthroscopic Release for Lateral Patellar Compression Syndrome: Comparative Study

NCT04130412

Sponsor

Hawler Medical University

Status

Completed

Last Update Posted

Jun 4, 2020Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Knee Arthroscopy

Interventions

open 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

Jun 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

Mar 5, 2016Actual

Primary Completion Date

Nov 10, 2019Actual

Completion Date

Nov 25, 2019Actual

First Submitted Date

Oct 13, 2019

First Submission Date that Met QC Criteria

Oct 15, 2019

First Posted Date

Oct 17, 2019Actual

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

Jun 3, 2020

Last Update Posted Date

Jun 4, 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)

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

Chronic anterior knee pain with a stable patella is often associated with overload and increased pressure on the lateral facet due to pathologic lateral soft-tissue restraints. "Lateral pressure in flexion" is a term describing the pathologic process of increasing contact pressure over the lateral patellar facet as knee flexion progresses. Eighty patients were involved in this study, and it was divided into 2 random groups; Group A (40 patients)(odd number) were treated with open release after diagnostic arthroscopy and Group B (40 patients)(even number) were treated by arthroscopic release. All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI and diagnostic arthroscopy. All patients were followed by Lysholm knee scaling score before surgery and two weeks , six weeks then 6 months after surgery.

Detailed Description

This study was done by two orthopedic surgeons working in three hospitals from March 2016 to April 2018, Eighty patients were involved in this study, and it was divided into 2 matched groups; Group A (40 patients) were treated with open release after diagnostic arthroscopy and Group B (40 patients) were treated by arthroscopic release. All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI ( figure 1)and diagnostic arthroscopy. All patients were followed by Lysol knee scaling score before surgery , two weeks , six weeks then 6 months after surgery. The two groups are matched related to age and gender. 52 patients are females and age ranged from 21-48 years.

Exclusion criteria are 1. Smoking 2.Patellar instability 3. D.M 4. Knee osteoarthritis 5. Previous knee surgery 6. Knee deformities involving Varus , valgus or recurvatum 7. Ligament laxity

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open release of lateral retinaculae	Active Comparator	This group was treated by open release of lateral retinaculae after diagnosis of lateral compression syndrome by arthroscopy	Procedure: open release
Arthroscopic release of lateral retinaculae	Active Comparator	This group was treated by arthroscopic release	Procedure: open release

Interventions

Name	Type	Description	Arm Group Labels	Other Names
open release	Procedure	Open release of lateral retinaculae	Arthroscopic release of lateral retinaculae Open release of lateral retinaculae

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lysholm knee scaling score	Measurement of knee pain and daily activities	All patients were followed by Lysholm knee scaling score 6 months after surgery.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI and diagnostic arthroscopy.

Exclusion Criteria:

Smoking
Patellar instability
D.M 4. Knee osteoarthritis

5. Previous knee surgery 6. Knee deformities involving Varus , valgus or recurvatum 7. Ligament laxity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

46 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33829300	Derived	Hamawandi SA, Amin HI, Al-Humairi AK. Open versus arthroscopic release for lateral patellar compression syndrome: a randomized-controlled trial. Arch Orthop Trauma Surg. 2022 Oct;142(10):1-7. doi: 10.1007/s00402-021-03878-0. Epub 2021 Apr 7.

ID	Term
D001182	Arthroscopy
D004724	Endoscopy
D019060	Minimally Invasive Surgical Procedures
D013514	Surgical Procedures, Operative