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Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Operative (partial arthroscopy)
Conservative (diagnostic arthroscopy)
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Knee, Arthroscopic Surgery, Menisci, Medial, Placebo Effect, Treatment Efficacy

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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
  • Hatanpää City Hospital
  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Operative (O)

Conservative (K)

Arm Description

Partial resection of degenerative tear of medial meniscus

Arthroscopy (diagnostic)

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

15-D (General Quality of Life -Assessment Tool)
The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).
Pain at Rest (VAS)
Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
Cost Effectiveness
Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.

Full Information

First Posted
October 24, 2007
Last Updated
December 20, 2022
Sponsor
Tampere University
Collaborators
Helsinki University Central Hospital, Kuopio University Hospital, Turku University Hospital, Central Finland Hospital District
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1. Study Identification

Unique Protocol Identification Number
NCT00549172
Brief Title
Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear
Official Title
Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy is the most common orthopaedic procedure and is used to treat patients with meniscal tears. Many patients report improvement after arthroscopy referring especially to reduced knee pain, better knee function and improved quality of life. However, similar results have also been obtained with conservative treatment (physical therapy) of patients with degenerative meniscal tears. 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. The outcome of arthroscopic partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the functional outcome is assessed using the WOMET knee score (a disease-specific quality of life -knee score development on the assessment of meniscal pathology), the general quality of life score (15-D), and cost-effectiveness analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Knee, Arthroscopic Surgery, Menisci, Medial, Placebo Effect, Treatment Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Operative (O)
Arm Type
Active Comparator
Arm Description
Partial resection of degenerative tear of medial meniscus
Arm Title
Conservative (K)
Arm Type
Sham Comparator
Arm Description
Arthroscopy (diagnostic)
Intervention Type
Procedure
Intervention Name(s)
Operative (partial arthroscopy)
Intervention Description
Partial arthroscopic resection of degenerative rupture of the medial meniscus
Intervention Type
Procedure
Intervention Name(s)
Conservative (diagnostic arthroscopy)
Intervention Description
Diagnostic arthroscopy
Primary Outcome Measure Information:
Title
The Lysholm Knee Score
Description
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.
Time Frame
One year
Title
Pain After Exercise (VAS)
Description
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.
Time Frame
One year
Title
WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
15-D (General Quality of Life -Assessment Tool)
Description
The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).
Time Frame
One year
Title
Pain at Rest (VAS)
Description
Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
Time Frame
One year
Title
Cost Effectiveness
Description
Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.
Time Frame
1 and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Teppo LN Jarvinen, MD, PhD
Organizational Affiliation
Tampere University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Raine TA Sihvonen, MD
Organizational Affiliation
Tampere City Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mika Paavola, MD, PhD
Organizational Affiliation
University of Helsinki
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antti Malmivaara, MD, PhD
Organizational Affiliation
University of Helsinki
Official's Role
Study Director
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
Hatanpää City Hospital
City
Tampere
ZIP/Postal Code
FI-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
PubMed Identifier
26856620
Citation
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.
Results Reference
derived
PubMed Identifier
24369076
Citation
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.
Results Reference
derived
PubMed Identifier
23474796
Citation
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.
Results Reference
derived

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Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

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