Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

This study has been completed.
Sponsor:
Collaborators:
Helsinki University Central Hospital
Kuopio University Hospital
Turku University Hospital
Central Finland Hospital District
Information provided by (Responsible Party):
Raine Sihvonen, University of Tampere
ClinicalTrials.gov Identifier:
NCT00549172
First received: October 24, 2007
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Procedure: Operative (partial arthroscopy)
Procedure: Conservative (diagnostic arthroscopy)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee

Resource links provided by NLM:


Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • The Lysholm knee score [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Pain after exercise (VAS) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • WOMET (Western Ontario Meniscal Tear -disease specific quality of life -assessment tool) [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 15-D (general quality of life -assessment tool) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Pain at rest (VAS) [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: October 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Operative (O)
Partial resection of degenerative tear of medial meniscus
Procedure: Operative (partial arthroscopy)
Partial arthroscopic resection of degenerative rupture of the medial meniscus
Sham Comparator: Conservative (K)
Arthroscopy (diagnostic)
Procedure: Conservative (diagnostic arthroscopy)
Diagnostic arthroscopy

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549172

Locations
Finland
Helsinki Central Hospital
Helsinki, Finland
Central Finland Hospital District
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Hatanpää City Hospital
Tampere, Finland, FI-33101
Turku University Hospital
Turku, Finland
Sponsors and Collaborators
University of Tampere
Helsinki University Central Hospital
Kuopio University Hospital
Turku University Hospital
Central Finland Hospital District
Investigators
Study Chair: Teppo LN Jarvinen, MD, PhD University of Tampere
Principal Investigator: Raine TA Sihvonen, MD Tampere City Hospital
Study Director: Mika Paavola, MD, PhD Helsinki University
Study Director: Antti Malmivaara, MD, PhD Helsinki University
  More Information

No publications provided by University of Tampere

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raine Sihvonen, Principal Investigator, University of Tampere
ClinicalTrials.gov Identifier: NCT00549172     History of Changes
Other Study ID Numbers: R06157
Study First Received: October 24, 2007
Last Updated: August 1, 2013
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by University of Tampere:
Osteoarthritis, Knee
Arthroscopic Surgery
Menisci, Medial
Placebo Effect
Treatment Efficacy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014