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Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01002794
First Posted: October 27, 2009
Last Update Posted: June 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Oslo University Hospital
October 25, 2009
October 27, 2009
June 2, 2014
November 2009
January 2015   (Final data collection date for primary outcome measure)
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: at 2 years ]
  • Isokinetic muscle strength tests for knee extensors and flexors [ Time Frame: at 3 months ]
  • Incident and enlarging marginal tibiofemoral osteophyte. [ Time Frame: At 5 years ]
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: at 2 years ]
  • Isokinetic muscle strength tests for knee extensors and flexors/ functional tests [ Time Frame: at 3 months ]
Complete list of historical versions of study NCT01002794 on ClinicalTrials.gov Archive Site
  • SF-36 and EQ5D [ Time Frame: 2 years ]
  • Isokinetic muscle strength tests for knee extensors and flexors [ Time Frame: 2 years ]
  • Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [ Time Frame: 2 years ]
  • Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [ Time Frame: At 3 months ]
  • SF-36 and EQ5D [ Time Frame: 2 years ]
  • Isokinetic muscle strength tests for knee extensors and flexors [ Time Frame: 2 years ]
  • Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears
The Effect of Arthroscopic Partial Meniscectomy or Exercise Therapy as Treatment of Degenerative Meniscus Tears in Middle-aged Patients. A Randomized, Controlled Trial

This study is conducted as a collaboration between NAR, Orthopedic Department, Oslo University Hospital,Ullevaal, Hjelp24Nimi Oslo, Norway, and University of Southern Denmark, Odense, Denmark.

The investigators hypothesize that exercise is more effective than arthroscopic partial meniscectomy: a) on self-reported outcomes, functional performance and muscle strength in middle-aged patients subsequent to arthroscopic partial meniscectomy for a degenerative meniscus tear, and b) in preventing further development of knee osteoarthritis (OA).

The aims of the study are:

  1. At 3 months, to investigate the effect of arthroscopic partial meniscectomy versus exercise therapy on muscle strength and knee function in middle-aged patients with degenerative meniscus lesions.
  2. At 2 years, to investigate the effect of arthroscopic partial meniscectomy versus exercise therapy on self-reported outcomes in middle aged patients with degenerative meniscus lesions.
  3. At 5 years, to describe radiographic changes in knee osteoarthritis development after arthroscopic partial meniscectomy or exercise therapy in middle-aged patients with degenerative meniscus lesions.

Patients included in the study will be randomized into one of two groups. The interventions are: arthroscopic partial meniscectomy and supervised neuromuscular- and strength training. Subjects will be tested before and after intervention, at 12 months, 24 months and finally at five years.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Degenerative Meniscal Tear
  • Procedure: Arthroscopic partial menisectomy
    Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital.
  • Other: Supervised neuromuscular and strength training
    Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training.
  • Experimental: Arthroscopic partial meniscectomy
    Standard arthroscopic partial meniscectomy - NGD 1
    Intervention: Procedure: Arthroscopic partial menisectomy
  • Experimental: Exercise Therapy
    Supervised neuromuscular- and strength training
    Intervention: Other: Supervised neuromuscular and strength training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
140
December 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 35-60 years
  • Knee pain for more than 2 months without a significant trauma
  • Medial meniscal tear on MRI
  • Eligible for arthroscopic partial meniscectomy
  • Grade 0-2 radiographic severity (specification after Kellgren Lawrence)

Exclusion Criteria:

  • Those requiring acute trauma surgeries, including those treated as acute cases in the ER
  • Ligament injuries
  • Tumours (MRI)
  • Pain or other musculoskeletal comorbidities severely affecting lower extremity muscle function overriding the symptoms from the knee
  • Grade 3 or 4 radiographic severity (specification after Kellgren Lawrence)
  • Comorbidities excluding physical activities and exercise.
  • Previous knee surgery within two years
  • Not able to speak or read Norwegian, drug abuse or mental problems
Sexes Eligible for Study: All
35 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01002794
NARSDU2009
Not Provided
Not Provided
Not Provided
Oslo University Hospital
Oslo University Hospital
University of Southern Denmark
Not Provided
Oslo University Hospital
May 2014

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