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Status unknownNCT01052233Updated Jan 21, 2015

Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear

A Phase 4 interventional study of Arthroscopic partial meniscectomy and Arthroscopy (diagnostic) in Osteoarthritis of the Knee, Arthroscopy and Meniscal Tear, sponsored by Tampere University. Status unknown at 5 sites in Finland. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-01-21.

Sponsored by Tampere University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

It has been previously demonstrated that the risk for the development/progression 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 (i.e., adverse mechanical effect on knee cartilage), the surgery (resection of the meniscus, and subsequent loss of cushion within the knee), 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.

Patients included in the study will be randomized into one of two groups: arthroscopic partial meniscectomy and diagnostic arthroscopy (sham-surgery). The presence of knee osteoarthritis will be assessed preoperatively and 2, 5, and 10 years after the operation.

02

Conditions studied

  • Osteoarthritis of the Knee
  • Arthroscopy
  • Meniscal Tear

Keywords

  • Sham-surgery
  • Development of osteoarthritis
  • Randomized, double-blinded, placebo-controlled
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's planned enrollment of 160 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Tampere University is the lead sponsor of 63 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    Arthroscopic partial meniscectomy

    Arthroscopic partial resection of degenerative tear of medial meniscus

    Procedure: Arthroscopic partial meniscectomy

  • Sham comparator
    Arthroscopy (diagnostic)

    Diagnostic arthroscopy of the knee

    Procedure: Arthroscopy (diagnostic)

Interventions

  • ProcedureArthroscopic partial meniscectomy

    Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus

  • ProcedureArthroscopy (diagnostic)

    Diagnostic arthroscopy of the knee

06

What researchers measure

Primary outcomes

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

    Time frame: 2 and 10 years postoperatively

Secondary outcomes

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

    Time frame: 2 and 10 years postoperatively

07

Study locations

5 sites
  • Helsinki Central Hospital
    Helsinki, Finland
  • Central Finland Hospital District
    Jyväskylä, Finland
  • Kuopio University Hospital
    Kuopio, Finland
  • Tampere City Hospital
    Tampere, 33101, Finland
  • Turku University Hospital
    Turku, Finland
08

References and documents

Publications

  • 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. PubMed 39277028 ↗
  • 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. PubMed 32855201 ↗
  • 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. PubMed 31937344 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Jan 2016 and a completion of Jan 2024. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2010
First posted
Jan 20, 2010
Start
Jan 2010
Primary completionEst.
Jan 2016
CompletionEst.
Jan 2024
Last update
Jan 21, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01052233
Lead sponsor
Tampere University
Collaborators
Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Central Finland Hospital District
Responsible party
Teppo Jarvinen (Principal Investigator, Tampere University) — Principal investigator
First posted
Jan 20, 2010
Start date
Jan 2010
Primary completion
Jan 2016 (estimated)
Completion
Jan 2024 (estimated)
Last update
Jan 21, 2015

Study contacts

Raine Sihvonen, MD
study chair · Tampere City Hospital
Teppo Järvinen, MD, PhD
principal investigator · Tampere University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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