Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee

Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Operative (partial arthroscopy); Procedure: Conservative (diagnostic arthroscopy)

Detailed Description

Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy is the most common orthopaedic procedure and is used to treat patients with meniscal tears. Many patients report improvement after arthroscopy referring especially to reduced knee pain, better knee function and improved quality of life. However, similar results have also been obtained with conservative treatment (physical therapy) of patients with degenerative meniscal tears. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial. The outcome of arthroscopic partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the functional outcome is assessed using the WOMET knee score (a disease-specific quality of life -knee score development on the assessment of meniscal pathology), the general quality of life score (15-D), and cost-effectiveness analysis.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki Central Hospital
  • Jyväskylä, Finland
    • Central Finland Hospital District
  • Kuopio, Finland
    • Kuopio University Hospital
  • Tampere, Finland, FI-33101
    • Hatanpää City Hospital
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: 35 to 65 years of age.
2. A pain located on the medial joint line of the knee that has persistent at least for 3 months.
3. Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.
4. Tear of the medial meniscus on MRI.
5. Degenerative rupture of the medial meniscus confirmed at arthroscopy.

Exclusion Criteria:

1. Acute, trauma-induced onset of symptoms.
2. Locking or painful snapping of the knee joint.
3. A surgical operation performed on the affected knee.
4. Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).
5. Osteoarthritis on knee radiographs (Kellgren-Lawrence > 1).
6. Acute (within the previous year) fractures of the knee.
7. Decreased range of motion of the knee.
8. Instability of the knee.
9. MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment.
10. Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Operative (O); Partial resection of degenerative tear of medial meniscus	Procedure: Operative (partial arthroscopy); Partial arthroscopic resection of degenerative rupture of the medial meniscus
Sham Comparator: Conservative (K); Arthroscopy (diagnostic)	Procedure: Conservative (diagnostic arthroscopy); Diagnostic arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Lysholm Knee Score	The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.	One year
Pain After Exercise (VAS)	Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.	One year
WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)	The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
15-D (General Quality of Life -Assessment Tool)	The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).	One year
Pain at Rest (VAS)	Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.	One year
Cost Effectiveness	Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.	1 and 2 years

Collaborators and Investigators

• Sponsor: Tampere University
• Collaborators: Turku University Hospital; Helsinki University Central Hospital; Kuopio University Hospital; Central Finland Hospital District
• Investigators: Study Director: Mika Paavola, MD, PhD, University of Helsinki; Study Chair: Teppo LN Jarvinen, MD, PhD, Tampere University; Principal Investigator: Raine TA Sihvonen, MD, Tampere City Hospital; Study Director: Antti Malmivaara, MD, PhD, University of Helsinki

Publications and helpful links

General Publications

• Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Kalske J, Nurmi H, Kumm J, Sillanpaa N, Kiekara T, Turkiewicz A, Toivonen P, Englund M, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscus Lesion Study) Investigators. Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Br J Sports Med. 2020 Nov;54(22):1332-1339. doi: 10.1136/bjsports-2020-102813. Epub 2020 Aug 27.
• Sihvonen R, Kalske R, Englund M, Turkiewicz A, Toivonen P, Taimela S, Jarvinen TLN; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Investigators. Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial. Trials. 2020 Jan 14;21(1):76. doi: 10.1186/s13063-019-3833-2.
• Sihvonen R, Englund M, Turkiewicz A, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study Group. Mechanical Symptoms and Arthroscopic Partial Meniscectomy in Patients With Degenerative Meniscus Tear: A Secondary Analysis of a Randomized Trial. Ann Intern Med. 2016 Apr 5;164(7):449-55. doi: 10.7326/M15-0899. Epub 2016 Feb 9.
• Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189.
• Sihvonen R, Paavola M, Malmivaara A, Jarvinen TL. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design. BMJ Open. 2013 Mar 9;3(3):e002510. doi: 10.1136/bmjopen-2012-002510.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: October 24, 2007
• First Submitted That Met QC Criteria: October 24, 2007
• First Posted (Estimate): October 25, 2007

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Placebo Effect; Osteoarthritis, Knee; Treatment Efficacy; Arthroscopic Surgery; Menisci, Medial
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: R06157