Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

Degenerative Meniscal Tear Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01002794
• Other study ID #: NARSDU2009
• Status: Active, not recruiting
• Phase: N/A
• First received: October 25, 2009
• Last updated: May 30, 2014
• Start date: November 2009
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Degenerative Meniscal Tear

Intervention

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.

Locations

Country	Name	City	State
Norway	Orthopaedic Department, Oslo University Hospital, Ullevaal	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		at 2 years	No
Primary	Isokinetic muscle strength tests for knee extensors and flexors		at 3 months	No
Primary	Incident and enlarging marginal tibiofemoral osteophyte.		At 5 years	No
Secondary	SF-36 and EQ5D		2 years	No
Secondary	Isokinetic muscle strength tests for knee extensors and flexors		2 years	No
Secondary	Two one-legged hop tests and maximal number of knee bendings in 30 seconds.		2 years	No
Secondary	Two one-legged hop tests and maximal number of knee bendings in 30 seconds.		At 3 months	No