NCT00549172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 23, 2015

Completed
Last Updated

January 13, 2023

Status Verified

December 1, 2022

Enrollment Period

5.4 years

First QC Date

October 24, 2007

Results QC Date

March 16, 2015

Last Update Submit

December 20, 2022

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, KneeArthroscopic SurgeryMenisci, MedialPlacebo EffectTreatment Efficacy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 15-D (General Quality of Life -Assessment Tool)

    One year

  • Pain at Rest (VAS)

    One year

  • Cost Effectiveness

    1 and 2 years

Study Arms (2)

Operative (O)

ACTIVE COMPARATOR

Partial resection of degenerative tear of medial meniscus

Procedure: Operative (partial arthroscopy)

Conservative (K)

SHAM COMPARATOR

Arthroscopy (diagnostic)

Procedure: Conservative (diagnostic arthroscopy)

Interventions

Operative (partial arthroscopy)PROCEDURE

Partial arthroscopic resection of degenerative rupture of the medial meniscus

Operative (O)
Conservative (diagnostic arthroscopy)PROCEDURE

Diagnostic arthroscopy

Conservative (K)

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Helsinki Central Hospital

Helsinki, Finland

Location

Central Finland Hospital District

Jyväskylä, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Hatanpää City Hospital

Tampere, FI-33101, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (7)

  • 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.

    PMID: 39277028DERIVED

  • 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.

    PMID: 38905520DERIVED

  • 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.

    PMID: 32855201DERIVED

  • 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.

    PMID: 31937344DERIVED

  • 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.

    PMID: 26856620DERIVED

  • 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.

    PMID: 24369076DERIVED

  • 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.

    PMID: 23474796DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Dr. Teppo Järvinen, Head of study chair
Organization
University of Helsinki
teppo.jarvinen@helsinki.fi

Study Officials

  • Teppo LN Jarvinen, MD, PhD

    Tampere University

    STUDY CHAIR

  • Raine TA Sihvonen, MD

    Tampere City Hospital

    PRINCIPAL INVESTIGATOR

  • Mika Paavola, MD, PhD

    University of Helsinki

    STUDY DIRECTOR

  • Antti Malmivaara, MD, PhD

    University of Helsinki

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 13, 2023

Results First Posted

March 23, 2015

Record last verified: 2022-12

Locations

FI(5)