Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

NCT ID: NCT00549172

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2013-03-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Operative (O)

Partial resection of degenerative tear of medial meniscus

Group Type: ACTIVE_COMPARATOR

Operative (partial arthroscopy)

Intervention Type: PROCEDURE

Partial arthroscopic resection of degenerative rupture of the medial meniscus

Conservative (K)

Arthroscopy (diagnostic)

Group Type: SHAM_COMPARATOR

Conservative (diagnostic arthroscopy)

Intervention Type: PROCEDURE

Diagnostic arthroscopy

Interventions

Operative (partial arthroscopy)

Partial arthroscopic resection of degenerative rupture of the medial meniscus

Intervention Type: PROCEDURE

Conservative (diagnostic arthroscopy)

Diagnostic arthroscopy

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Central Finland Hospital District

OTHER

Sponsor Role: collaborator

Tampere University

OTHER

Sponsor Role: lead

Responsible Party

Raine Sihvonen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teppo LN Jarvinen, MD, PhD

Role: STUDY_CHAIR

Tampere University

Raine TA Sihvonen, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere City Hospital

Mika Paavola, MD, PhD

Role: STUDY_DIRECTOR

University of Helsinki

Antti Malmivaara, MD, PhD

Role: STUDY_DIRECTOR

University of Helsinki

Locations

Helsinki Central Hospital

Helsinki, , Finland

Central Finland Hospital District

Jyväskylä, , Finland

Kuopio University Hospital

Kuopio, , Finland

Hatanpää City Hospital

Tampere, , Finland

Turku University Hospital

Turku, , Finland

Countries

Finland

References

Sillanpaa N, Iivanainen M, Turkiewicz A, Sihvonen R, Paavola M, Taimela S, Jarvinen TLN, Englund M. Effect of arthroscopic partial meniscectomy on structural degeneration of the knee - A 5-year MRI-based follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Osteoarthritis Cartilage. 2025 Feb;33(2):276-282. doi: 10.1016/j.joca.2024.09.003. Epub 2024 Sep 12.

Reference Type: DERIVED

PMID: 39277028 (View on PubMed)

Kalske R, Kiadaliri A, Sihvonen R, Englund M, Turkiewicz A, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Toivonen P, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscal Lesion Study) Investigators. Arthroscopic Partial Meniscectomy for a Degenerative Meniscus Tear Is Not Cost Effective Compared With Placebo Surgery: An Economic Evaluation Based on the FIDELITY Trial Data. Clin Orthop Relat Res. 2024 Sep 1;482(9):1523-1533. doi: 10.1097/CORR.0000000000003094. Epub 2024 May 7.

Reference Type: DERIVED

PMID: 38905520 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32855201 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31937344 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26856620 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24369076 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23474796 (View on PubMed)

Other Identifiers

R06157

Identifier Type: -

Identifier Source: org_study_id