Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

• ClinicalTrials.gov Identifier: NCT00549172
• Recruitment Status: Completed
• First Posted: October 25, 2007
• Results First Posted: March 23, 2015
• Last Update Posted: January 13, 2023
• Sponsor: Tampere University
• Collaborators: Helsinki University Central Hospital; Kuopio University Hospital; Turku University Hospital; Central Finland Hospital District
• Information provided by (Responsible Party): Raine Sihvonen, Tampere University

Tracking Information

• First Submitted Date: October 24, 2007
• First Posted Date: October 25, 2007
• Results First Submitted Date: March 16, 2015
• Results First Posted Date: March 23, 2015
• Last Update Posted Date: January 13, 2023
• Study Start Date: October 2007
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2015)

• The Lysholm Knee Score [ Time Frame: One year ]
  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.
• Pain After Exercise (VAS) [ Time Frame: One year ]
  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.
• WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) [ Time Frame: One year ]
  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.

Original Primary Outcome Measures (submitted: October 24, 2007)

• The Lysholm knee score [ Time Frame: One year ]
• pain at rest and activity (VAS) [ Time Frame: One year ]

Current Secondary Outcome Measures (submitted: May 24, 2018)

• 15-D (General Quality of Life -Assessment Tool) [ Time Frame: One year ]
  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).
• Pain at Rest (VAS) [ Time Frame: One year ]
  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.
• Cost Effectiveness [ Time Frame: 1 and 2 years ]
  Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.

Original Secondary Outcome Measures (submitted: October 24, 2007)

• WOMET (Western Ontario Meniscal Tear -disease specific quality of life -assessment tool) [ Time Frame: One year ]
• 15-D (general quality of life -assessment tool) [ Time Frame: One year ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
• Official Title: Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee
• Brief Summary: 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Osteoarthritis, Knee

Intervention

• Procedure: Operative (partial arthroscopy)
  Partial arthroscopic resection of degenerative rupture of the medial meniscus
• Procedure: Conservative (diagnostic arthroscopy)
  Diagnostic arthroscopy

Study Arms

• Active Comparator: Operative (O)
  Partial resection of degenerative tear of medial meniscus
  Intervention: Procedure: Operative (partial arthroscopy)
• Sham Comparator: Conservative (K)
  Arthroscopy (diagnostic)
  Intervention: Procedure: Conservative (diagnostic arthroscopy)

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 17, 2013): 146
• Original Estimated Enrollment (submitted: October 24, 2007): 140
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT00549172
• Other Study ID Numbers: R06157
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Raine Sihvonen, Tampere University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Tampere University
• Original Study Sponsor: Same as current

Collaborators

• Helsinki University Central Hospital
• Kuopio University Hospital
• Turku University Hospital
• Central Finland Hospital District

Investigators

• Study Chair: Teppo LN Jarvinen, MD, PhD; Tampere University
• Principal Investigator: Raine TA Sihvonen, MD; Tampere City Hospital
• Study Director: Mika Paavola, MD, PhD; University of Helsinki
• Study Director: Antti Malmivaara, MD, PhD; University of Helsinki

• PRS Account: Tampere University
• Verification Date: December 2022