Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

This study is ongoing, but not recruiting participants.

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: January 30, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 24, 2007

Last Updated Date

January 30, 2012

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The Lysholm knee score [ Time Frame: One year ] [ Designated as safety issue: No ]
pain at rest and activity (VAS) [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The Lysholm knee score [ Time Frame: One year ]
pain at rest and activity (VAS) [ Time Frame: One year ]

Change History

Complete list of historical versions of study NCT00549172 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

WOMET (Western Ontario Meniscal Tear -disease specific quality of life -assessment tool) [ Time Frame: One year ] [ Designated as safety issue: No ]
15-D (general quality of life -assessment tool) [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

WOMET (Western Ontario Meniscal Tear -disease specific quality of life -assessment tool) [ Time Frame: One year ]
15-D (general quality of life -assessment tool) [ Time Frame: One year ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

Official Title ^ICMJE

Efficacy of Arthroscopic Partial Resection for the Degenerative Tear of the Medial Meniscus of a Knee

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Degenerative Tear of the Medial Meniscus of Knee

Intervention ^ICMJE

Procedure: Operative (partial arthroscopy)
Partial arthroscopic resection of degenerative rupture of the medial meniscus
Procedure: Conservative (diagnostic arthroscopy)
Diagnostic arthroscopy

Study Arm (s)

Active Comparator: Operative (O)
Partial resection of degenerative tear of medial meniscus

Intervention: Procedure: Operative (partial arthroscopy)
Sham Comparator: Conservative (K)
Arthroscopy (diagnostic)

Intervention: Procedure: Conservative (diagnostic arthroscopy)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

140

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

35 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00549172

Other Study ID Numbers ^ICMJE

R06157

Has Data Monitoring Committee

Yes

Responsible Party

Raine Sihvonen, University of Tampere

Study Sponsor ^ICMJE

University of Tampere

Collaborators ^ICMJE

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

Investigators ^ICMJE

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

Information Provided By

University of Tampere

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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