NCT04130412

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Status
completed

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

March 5, 2016

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

3.7 years

First QC Date

October 13, 2019

Last Update Submit

June 3, 2020

Conditions

Keywords

Lateral patellar compression syndromeArthroscopic releaseOpen release

Outcome Measures

Primary Outcomes (1)

  • Lysholm knee scaling score

    Measurement of knee pain and daily activities

    All patients were followed by Lysholm knee scaling score 6 months after surgery.

Study Arms (2)

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

open releasePROCEDURE

Open release of lateral retinaculae

Also known as: Arthroscopic release
Arthroscopic release of lateral retinaculaeOpen release of lateral retinaculae

Eligibility Criteria

Age25 Years - 46 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Smoking
  • Patellar instability
  • D.M 4. Knee osteoarthritis
  • \. Previous knee surgery 6. Knee deformities involving Varus , valgus or recurvatum 7. Ligament laxity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Joint Capsule Release

Intervention Hierarchy (Ancestors)

ArthroscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of orthopedic surgery

Study Record Dates

First Submitted

October 13, 2019

First Posted

October 17, 2019

Study Start

March 5, 2016

Primary Completion

November 10, 2019

Study Completion

November 25, 2019

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share