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: May 30, 2014
Last verified: May 2014
  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 Meniscal 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 2015
Estimated Primary Completion Date: January 2015 (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
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: 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: May 30, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Lacerations
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 18, 2014