Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01002794
First received: October 25, 2009
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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 Intervention
Degenerative Meniscus Tear
Procedure: Arthroscopic partial menisectomy
Other: Supervised neuromuscular and strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Isokinetic muscle strength tests for knee extensors and flexors [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • Incident and enlarging marginal tibiofemoral osteophyte. [ Time Frame: At 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 and EQ5D [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Isokinetic muscle strength tests for knee extensors and flexors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Two one-legged hop tests and maximal number of knee bendings in 30 seconds. [ Time Frame: At 3 months ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: November 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002794

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

Additional Information:
No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01002794     History of Changes
Other Study ID Numbers: NARSDU2009
Study First Received: October 25, 2009
Last Updated: June 10, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Degenerative meniscus tear
Arthroscopy
Exercise therapy

Additional relevant MeSH terms:
Lacerations
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014