NCT01052233

Brief Summary

It has been previously demonstrated that the risk for the development of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se, the surgery, or whether the development of knee osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to investigate the effect of arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
unknown

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

January 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

6 years

First QC Date

January 19, 2010

Last Update Submit

January 20, 2015

Conditions

Keywords

Sham-surgeryDevelopment of osteoarthritisRandomized, double-blinded, placebo-controlled

Outcome Measures

Primary Outcomes (1)

  • Radiological assessment of OA of the knee (Kellgren-Lawrence -classification)

    2 and 10 years postoperatively

Secondary Outcomes (1)

  • ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee

    2 and 10 years postoperatively

Study Arms (2)

Arthroscopic partial meniscectomy

ACTIVE COMPARATOR

Arthroscopic partial resection of degenerative tear of medial meniscus

Procedure: Arthroscopic partial meniscectomy

Arthroscopy (diagnostic)

SHAM COMPARATOR

Diagnostic arthroscopy of the knee

Procedure: Arthroscopy (diagnostic)

Interventions

Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus

Arthroscopic partial meniscectomy

Diagnostic arthroscopy of the knee

Arthroscopy (diagnostic)

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
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

Tampere City Hospital

Tampere, 33101, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (3)

  • 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.

  • 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic Procedures

Study Officials

  • Raine Sihvonen, MD

    Tampere City Hospital

    STUDY CHAIR
  • Teppo Järvinen, MD, PhD

    Tampere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 20, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2016

Study Completion

January 1, 2024

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations