Medial Plica Syndrome of the Knee: Conservative Treatment Versus Arthroscopic Plica Resection - a Randomized Controlled Multicenter Trial

Not Applicable

• Conditions: Plica Mediopatellaris
• Interventions: Procedure: Plica resection vs conservative treatment

• Registration Number: NCT02578589
• Lead Sponsor: Regionshospitalet Silkeborg

Brief Summary

The purpose of this trial is to evaluate the effect of conservative treatment in comparison to arthroscopic resection of pathological medial plicae of the knee for patients with medial plica syndrome. The investigators expect conservative treatment to be significantly superior to arthroscopic plica resection with regard to symptom remission and return to prior functional level.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-10-11
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-06
• Last Update Posted: 2017-10-09
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Aged over 18 years
• History of antermedial knee pain
• Palpable medial band in clinical examination or medial plica appearence on MRI
• Absence of all of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
• Given declaration of consent
• Joining a fitness centre for the duration of minimum 3 months at their own expense.

Exclusion Criteria

Aged under 18 years

• Presence of one or more of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
• Prior surgical intervention, infection, fracture or patellar luxation concerning the relevant knee
• Not willing to join a fitness centre for the duration of minimum 3 months at their own expense

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery	Plica resection vs conservative treatment	-
Conservative treatment	Plica resection vs conservative treatment	-

Primary Outcome Measures

Name	Time	Method
Lysholm-Scale (Units on a scale)	2 years	Difference of minimum 5 points concerning the average scoring outcome on the Lysholm Knee Scoring Scala in favor of patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)

Secondary Outcome Measures

Name	Time	Method
QOL-Scale (Units on a scale)	2 years	Higher average scoring outcome on the Quality of Life Scala (extracted from KOOS) in favor of patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)
VAS-Scale (Visual Analog Scale for pain) (Units on a scale)	2 years	Lower average results on Visual Anologue Scale concerning knee pain while walking indicated by patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)
Kujala-Scale (Units on a scale)	2 years	Secondary endpoints: Higher average scoring outcome on the Anterior Knee Pain Scala (Kujala) in favor of patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Lower average results on Visual Anologue Scale concerning knee pain while walking indicated by patients undergoing conservative treatment in comparison to patients undergoing arthroscopic plica resection at 2 year follow up. Units of measure (Units on a scale)

Trial Locations

Locations (2)

Regionshospitalet Silkeborg; 🇩🇰 Silkeborg, Denmark

Regionshospital Silkeborg; 🇩🇰 Silkeborg, Denmark