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

Study Overview
=================
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.

Conditions
-----------------
Plica Mediopatellaris

Intervention / Treatment
-----------------
* Procedure: Plica resection vs conservative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery<br> | Procedure: Plica resection vs conservative treatment<br>* Plica resection vs conservative treatment<br>|
| Active Comparator: Conservative treatment<br> | Procedure: Plica resection vs conservative treatment<br>* Plica resection vs conservative treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm-Scale (Units on a scale) | 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) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kujala-Scale (Units on a scale) | 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) | 2 years | 
| QOL-Scale (Units on a scale) | 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) | 2 years | 
| VAS-Scale (Visual Analog Scale for pain) (Units on a scale) | 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) | 2 years |