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

Primary Purpose

Osteoarthritis of the Knee, Arthroscopy, Meniscal Tear

Status
Enrolling by invitation
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Arthroscopic partial meniscectomy
Arthroscopy (diagnostic)
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis of the Knee focused on measuring Sham-surgery, Development of osteoarthritis, Randomized, double-blinded, placebo-controlled

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arthroscopic partial meniscectomy

Arthroscopy (diagnostic)

Arm Description

Arthroscopic partial resection of degenerative tear of medial meniscus

Diagnostic arthroscopy of the knee

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2010
Last Updated
January 20, 2015
Sponsor
Tampere University
Collaborators
Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Central Finland Hospital District
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1. Study Identification

Unique Protocol Identification Number
NCT01052233
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?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Helsinki University Central Hospital, Turku University Hospital, Kuopio University Hospital, Central Finland Hospital District

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee, Arthroscopy, Meniscal Tear
Keywords
Sham-surgery, Development of osteoarthritis, Randomized, double-blinded, placebo-controlled

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopic partial meniscectomy
Arm Type
Active Comparator
Arm Description
Arthroscopic partial resection of degenerative tear of medial meniscus
Arm Title
Arthroscopy (diagnostic)
Arm Type
Sham Comparator
Arm Description
Diagnostic arthroscopy of the knee
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic partial meniscectomy
Intervention Description
Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus
Intervention Type
Procedure
Intervention Name(s)
Arthroscopy (diagnostic)
Intervention Description
Diagnostic arthroscopy of the knee
Primary Outcome Measure Information:
Title
Radiological assessment of OA of the knee (Kellgren-Lawrence -classification)
Time Frame
2 and 10 years postoperatively
Secondary Outcome Measure Information:
Title
ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee
Time Frame
2 and 10 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raine Sihvonen, MD
Organizational Affiliation
Tampere City Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Teppo Järvinen, MD, PhD
Organizational Affiliation
Tampere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki Central Hospital
City
Helsinki
Country
Finland
Facility Name
Central Finland Hospital District
City
Jyväskylä
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
Tampere City Hospital
City
Tampere
ZIP/Postal Code
33101
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32855201
Citation
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.
Results Reference
derived
PubMed Identifier
31937344
Citation
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.
Results Reference
derived

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

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