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

• ClinicalTrials.gov Identifier: NCT01052233
• Recruitment Status: Enrolling by invitation
• First Posted: January 20, 2010
• Last Update Posted: January 21, 2015
• Sponsor: Tampere University
• Collaborators: Helsinki University Central Hospital; Turku University Hospital; Kuopio University Hospital; Central Finland Hospital District
• Information provided by (Responsible Party): Teppo Jarvinen, Tampere University

Tracking Information

• First Submitted Date: January 19, 2010
• First Posted Date: January 20, 2010
• Last Update Posted Date: January 21, 2015
• Study Start Date: January 2010
• Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 19, 2010): Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) [ Time Frame: 2 and 10 years postoperatively ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 19, 2010): ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee [ Time Frame: 2 and 10 years postoperatively ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear
• Official Title: Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg?
• 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.

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Osteoarthritis of the Knee
• Arthroscopy
• Meniscal Tear

Intervention

• Procedure: Arthroscopic partial meniscectomy
  Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus
• Procedure: Arthroscopy (diagnostic)
  Diagnostic arthroscopy of the knee

Study Arms

• Active Comparator: Arthroscopic partial meniscectomy
  Arthroscopic partial resection of degenerative tear of medial meniscus
  Intervention: Procedure: Arthroscopic partial meniscectomy
• Sham Comparator: Arthroscopy (diagnostic)
  Diagnostic arthroscopy of the knee
  Intervention: Procedure: Arthroscopy (diagnostic)

Publications *

• Sihvonen R, Paavola M, Malmivaara A, Itälä A, Joukainen A, Kalske J, Nurmi H, Kumm J, Sillanpää N, Kiekara T, Turkiewicz A, Toivonen P, Englund M, Taimela S, Järvinen 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, Järvinen 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.

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: January 19, 2010): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2024
• Estimated Primary Completion Date: January 2016 (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: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT01052233
• Other Study ID Numbers: 9037/403/2006
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Teppo Jarvinen, Tampere University
• Study Sponsor: Tampere University

Collaborators

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

Investigators

• Study Chair: Raine Sihvonen, MD; Tampere City Hospital
• Principal Investigator: Teppo Järvinen, MD, PhD; Tampere University

• PRS Account: Tampere University
• Verification Date: January 2015