Clinical trial NCT01002794: Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Meniscal Tear
Keywords: Degenerative meniscal tear
Arthroscopy
Exercise therapy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: South-Eastern Norway Regional Health Authority
First posted: 2009-10-27
Enrollment: 140
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted as a collaboration between NAR, Orthopedic Department, Oslo University Hospital,Ullevaal, Hjelp24Nimi Oslo, Martina Hansens Hospital 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).

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.
4. 4. At 10 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, five and 10 years.

Long-term follow-up studies are particularly important for this patient population. Both meniscal tears and partial meniscectomy has been demonstrated as risk factors for incident knee osteoarthritis and progression. However, it is not known whether the increased risk is due to the meniscal tear per se or resection of the meniscus. Furthermore, patients presenting with symptomatic degenerative meniscal tears have reduced knee muscle strength, which may be an additional risk factor for knee osteoarthritis. While knee muscle weakness has been shown to persist following surgery, the knowledge of long-term changes following surgical and non-surgical interventions for degenerative meniscal tears is limited. Accordingly, long-term between-group differences in muscle strength changes (at 5 and 10 years) and radiographic knee osteoarthritis changes (10 years) will also be investigated

Eligibility 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

Primary outcomes:
measure: KOOS4 - Change From Baseline
timeFrame: 24 months
measure: Peak Torque Knee Extension - Change From Baseline
timeFrame: at 3 months
measure: Peak Torque Knee Flexion - Change From Baseline
timeFrame: 3 months
measure: Knee Osteoarthritis Incidence
timeFrame: 5 years
measure: Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years]
timeFrame: 10 years
Secondary outcomes:
measure: One Leg Hop Test - Change From Baseline
timeFrame: 3 months
measure: 6 Meter Timed Hop Test - Change From Baseline
timeFrame: 3 months
measure: Knee Bends 30 Sec - Change From Baseline
timeFrame: 3 months
measure: Peak Torque Knee Extension - Change From Baseline
timeFrame: 1 year
measure: Peak Torque Knee Flexion - Change From Baseline
timeFrame: 12 months
measure: One-leg Hop Test - Change in From Baseline
timeFrame: 12 months
measure: 6 Meter Timed Hop Test - Change From Baseline
timeFrame: 12 months
measure: Knee Bends 30 Sec - Change From Baseline
timeFrame: 12 months
measure: KOOS Pain - Change From Baseline
timeFrame: 24 months
measure: KOOS Symptoms - Change From Baseline
timeFrame: 24 months
measure: KOOS ADL - Change From Baseline
timeFrame: 24 months
measure: KOOS Sport/Rec - Change From Baseline
timeFrame: 24 months
measure: KOOS QOL - Change From Baseline
timeFrame: 24 months
measure: SF-36 MCS - Change From Baseline
timeFrame: 24 months
measure: SF-36 PCS - Change From Baseline
timeFrame: 24 months
measure: KOOS Pain Subscale - Change From Baseline
timeFrame: 5 years
measure: KOOS Symptoms Subscale - Change From Baseline
timeFrame: 5 years
measure: KOOS ADL Subscale - Change From Baseline
timeFrame: 5 years
measure: KOOS Sport/Rec Subscale - Change From Baseline
timeFrame: 5 years
measure: KOOS QOL Subscale - Change From Baseline
timeFrame: 5 years
measure: Peak Torque Knee Extension - Change From Baseline
timeFrame: 5 years
measure: Peak Torque Knee Flexion - Change From Baseline
timeFrame: 5 years
measure: Knee Osteoarthritis Incidence (Kellgren and Lawrence Classification )
timeFrame: 10 years
measure: KOOS4 - Change From Baseline
timeFrame: 10 years
measure: KOOS Pain Subscale - Change From Baseline
timeFrame: 10 years
measure: KOOS Symptoms Subscale - Change From Baseline
timeFrame: 10 years
measure: KOOS ADL Subscale - Change From Baseline
timeFrame: 10 years
measure: KOOS Sport/Rec Subscale - Change From Baseline
timeFrame: 10 years
measure: KOOS QOL Subscale - Change From Baseline
timeFrame: 10 years
measure: Peak Torque Knee Flexion - Change From Baseline
timeFrame: 10 years
measure: Peak Torque Knee Extension - Change From Baseline
timeFrame: 10 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Orthopaedic Department, Oslo University Hospital, Ullevaal
Study officials:
affiliation: Oslo University Hospital
name: May Arna Risberg, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stensrud S, Risberg MA, Roos EM. Effect of exercise therapy compared with arthroscopic surgery on knee muscle strength and functional performance in middle-aged patients with degenerative meniscus tears: a 3-mo follow-up of a randomized controlled trial. Am J Phys Med Rehabil. 2015 Jun;94(6):460-73. doi: 10.1097/PHM.0000000000000209.
citation: Kise NJ, Roos EM, Stensrud S, Engebretsen L, Risberg MA. The 6-m timed hop test is a prognostic factor for outcomes in patients with meniscal tears treated with exercise therapy or arthroscopic partial meniscectomy: a secondary, exploratory analysis of the Odense-Oslo meniscectomy versus exercise (OMEX) trial. Knee Surg Sports Traumatol Arthrosc. 2019 Aug;27(8):2478-2487. doi: 10.1007/s00167-018-5241-7. Epub 2018 Nov 16.
citation: Kise NJ, Aga C, Engebretsen L, Roos EM, Tariq R, Risberg MA. Complex Tears, Extrusion, and Larger Excision Are Prognostic Factors for Worse Outcomes 1 and 2 Years After Arthroscopic Partial Meniscectomy for Degenerative Meniscal Tears: A Secondary Explorative Study of the Surgically Treated Group From the Odense-Oslo Meniscectomy Versus Exercise (OMEX) Trial. Am J Sports Med. 2019 Aug;47(10):2402-2411. doi: 10.1177/0363546519858602. Epub 2019 Jul 12.
citation: Berg B, Roos EM, Kise NJ, Engebretsen L, Holm I, Risberg MA. On a Trajectory for Success-9 in Every 10 People With a Degenerative Meniscus Tear Have Improved Knee Function Within 2 Years After Treatment: A Secondary Exploratory Analysis of a Randomized Controlled Trial. J Orthop Sports Phys Ther. 2021 Jun;51(6):289-297. doi: 10.2519/jospt.2021.10025. Epub 2021 May 10.
citation: Kise NJ, Risberg MA, Stensrud S, Ranstam J, Engebretsen L, Roos EM. Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up. BMJ. 2016 Jul 20;354:i3740. doi: 10.1136/bmj.i3740.
citation: Berg B, Roos EM, Englund M, Kise NJ, Tiulpin A, Saarakkala S, Engebretsen L, Eftang CN, Holm I, Risberg MA. Development of osteoarthritis in patients with degenerative meniscal tears treated with exercise therapy or surgery: a randomized controlled trial. Osteoarthritis Cartilage. 2020 Jul;28(7):897-906. doi: 10.1016/j.joca.2020.01.020. Epub 2020 Mar 14.
citation: Berg B, Roos EM, Kise NJ, Engebretsen L, Holm I, Risberg MA. Muscle Strength and Osteoarthritis Progression After Surgery or Exercise for Degenerative Meniscal Tears: Secondary Analyses of a Randomized Trial. Arthritis Care Res (Hoboken). 2022 Jan;74(1):70-78. doi: 10.1002/acr.24736.
citation: Kise NJ, Risberg MA, Stensrud S, Ranstam J, Engebretsen L, Roos EM. Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: randomised controlled trial with two year follow-up. Br J Sports Med. 2016 Dec;50(23):1473-1480. doi: 10.1136/bjsports-2016-i3740rep.
citation: Stensrud S, Roos EM, Risberg MA. A 12-week exercise therapy program in middle-aged patients with degenerative meniscus tears: a case series with 1-year follow-up. J Orthop Sports Phys Ther. 2012 Nov;42(11):919-31. doi: 10.2519/jospt.2012.4165. Epub 2012 Sep 5.