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Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

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ClinicalTrials.gov Identifier: NCT01002794
Recruitment Status : Unknown
Verified May 2014 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 27, 2009
Last Update Posted : June 2, 2014
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:

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).


Condition or disease Intervention/treatment
Degenerative Meniscal Tear Procedure: Arthroscopic partial menisectomy Other: Supervised neuromuscular and strength training

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Arthroscopic Partial Meniscectomy or Exercise Therapy as Treatment of Degenerative Meniscus Tears in Middle-aged Patients. A Randomized, Controlled Trial
Study Start Date : November 2009
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arthroscopic partial meniscectomy
Standard arthroscopic partial meniscectomy - NGD 1
Procedure: Arthroscopic partial menisectomy
Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital.
Experimental: Exercise Therapy
Supervised neuromuscular- and strength training
Other: Supervised neuromuscular and strength training
Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training.



Primary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: at 2 years ]
  2. Isokinetic muscle strength tests for knee extensors and flexors [ Time Frame: at 3 months ]
  3. Incident and enlarging marginal tibiofemoral osteophyte. [ Time Frame: At 5 years ]

Secondary Outcome Measures :
  1. SF-36 and EQ5D [ Time Frame: 2 years ]
  2. Isokinetic muscle strength tests for knee extensors and flexors [ Time Frame: 2 years ]
  3. Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [ Time Frame: 2 years ]
  4. Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [ Time Frame: At 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002794


Locations
Norway
Orthopaedic Department, Oslo University Hospital, Ullevaal
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
University of Southern Denmark