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

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.

Study Overview

• Status: Unknown
• Conditions: Plica Mediopatellaris
• Intervention / Treatment: Procedure: Plica resection vs conservative treatment

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Silkeborg, Denmark, 8600
    • Recruiting
    • Regionshospital Silkeborg
    • Contact: Steffen Sauer; Phone Number: 04531560149; Email: sauer_steven@web.de
  • Silkeborg, Denmark, 8600
    • Recruiting
    • Regionshospitalet Silkeborg
    • Contact: Steffen Sauer; Phone Number: 04531560149; Email: sauer_steven@web.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conservative treatment	Procedure: Plica resection vs conservative treatment; Plica resection vs conservative treatment
Active Comparator: surgery	Procedure: Plica resection vs conservative treatment; Plica resection vs conservative treatment

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

Collaborators and Investigators

• Sponsor: Regionshospitalet Silkeborg

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 11, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 280981PM