Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears (OMEX)

The Effect of Arthroscopic Partial Meniscectomy or Exercise Therapy as Treatment of Degenerative Meniscus Tears in Middle-aged Patients. A Randomized, Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Degenerative Meniscal Tear
• Intervention / Treatment: 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.
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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Orthopaedic Department, Oslo University Hospital, Ullevaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 and Martina Hansens 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. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS4 - Change From Baseline	The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a patient administered questionnaire containing 42 questions in 5 subscales concerning patient´s knee related pain, other knee symptoms, activity of daily life, sport and recreation and quality of life.Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS4 is a composite score of the mean values of four of the five KOOS subscales (KOOS Pain, KOOS Symptoms, KOOS Sport/Rec and KOOS QOL).	24 months
Peak Torque Knee Extension - Change From Baseline	Peak torque knee extension (Newton meter) - Change from baseline	at 3 months
Peak Torque Knee Flexion - Change From Baseline	Peak torque knee flexion (Newton meter) - Change from baseline	3 months
Knee Osteoarthritis Incidence	In line with baseline assessment of the tibiofemoral joint, standing radiographs of the tibiofemoral joint is taken bilaterally with a Synaflexer Frame (Synarc Inc) that ensure alignment of the x-ray beam and standardize the placement of the knee in approximately 20 degrees of flexion and 5 degrees of external rotation for an anterior-posterior view. A sagittal view is also taken with the knee in flexion. Kellgren and Lawrence will be used for classification in addition to description of osteophytes and joint Space narrowing (JSN) will be measured.	5 years
Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years]	Radiographic progression based on the sum of marginal tibiofemoral osteophyte grades and tibiofemoral joint space narrowing (the Osteoarthritis Research Society International [OARSI] atlas) [Time Frame: At 10 years]	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One Leg Hop Test - Change From Baseline	Change in distance (meters) hopped on the One leg hop test from baseline to three months (higher is better).	3 months
6 Meter Timed Hop Test - Change From Baseline	Change in time (seconds) on the 6 meter timed hop test from baseline to 3 months (lower is better)	3 months
Knee Bends 30 Sec - Change From Baseline	Change in number of repetitions performed on the Knee bends 30 seconds test from baseline to 3 months (higher is better).	3 months
Peak Torque Knee Extension - Change From Baseline	Change in Peak torque knee extension (Newton meter) from baseline to 12 months (higher is better).	1 year
Peak Torque Knee Flexion - Change From Baseline	Change in Peak torque knee flexion (Newton meter) from baseline to 12 months (higher is better).	12 months
One-leg Hop Test - Change in From Baseline	Change in distance (meters) hopped on the One leg hop test from baseline to 12 months (higher is better).	12 months
6 Meter Timed Hop Test - Change From Baseline	Change in time (seconds) on the 6 meter timed hop test from baseline to 12 months (lower is better).	12 months
Knee Bends 30 Sec - Change From Baseline	Change in number of repetitions performed on the Knee bends 30 seconds test from baseline to 12 months (higher is better).	12 months
KOOS Pain - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	24 months
KOOS Symptoms - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	24 months
KOOS ADL - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities in Daily Living (ADL) subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale	24 months
KOOS Sport/Rec - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and recreation (Sport/Rec) subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	24 months
KOOS QOL - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale from baseline to two years. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	24 months
SF-36 MCS - Change From Baseline	Change in Short form 36 mental component summary (SF-36 MCS) from baseline to 24 months (range: 0-100; higher is better)	24 months
SF-36 PCS - Change From Baseline	Change in Short form 36 physical component summary (SF-36 PCS) from baseline to 24 months (range: 0-100; higher is better)	24 months
KOOS Pain Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to five years (range: 0-100; higher is better).	5 years
KOOS Symptoms Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to five years (range: 0-100; higher is better).	5 years
KOOS ADL Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) subscale from baseline to five years (range: 0-100; higher is better).	5 years
KOOS Sport/Rec Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and Recreation (Sport/Rec) subscale from baseline to five years (range: 0-100; higher is better).	5 years
KOOS QOL Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale from baseline to five years (range: 0-100; higher is better).	5 years
Peak Torque Knee Extension - Change From Baseline	Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to five years (higher is better).	5 years
Peak Torque Knee Flexion - Change From Baseline	Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to five years (higher is better).	5 years
Knee Osteoarthritis Incidence (Kellgren and Lawrence Classification )	Knee osteoarthritis incidence (Kellgren and Lawrence classification) [ Time Frame: 10 years]	10 years
KOOS4 - Change From Baseline	Change in KOOS4 from baseline to 10 years (range: 0-100; higher is better). KOOS4 is a composite score of the mean values of four of the five Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS Pain, KOOS Symptoms, KOOS Sport/Rec and KOOS QOL).	10 years
KOOS Pain Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to 10 years (range: 0-100; higher is better).	10 years
KOOS Symptoms Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to 10 years (range: 0-100; higher is better).	10 years
KOOS ADL Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) subscale from baseline to 10 years (range: 0-100; higher is better).	10 years
KOOS Sport/Rec Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport and recreation (Sport/Rec) subscale from baseline to five years (range: 0-100; higher is better).	10 years
KOOS QOL Subscale - Change From Baseline	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale from baseline to ten years (range: 0-100; higher is better).	10 years
Peak Torque Knee Flexion - Change From Baseline	Change in body weight (kilograms) normalized Peak torque knee flexion (Newton meter/kg) from baseline to ten years (higher is better).	10 years
Peak Torque Knee Extension - Change From Baseline	Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to 10 years (higher is better).	10 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Southern Denmark; South-Eastern Norway Regional Health Authority
• Investigators: Principal Investigator: May Arna Risberg, PT, PhD, Oslo University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: BMJ. 2017 Jan 17;356:j266. doi: 10.1136/bmj.j266. BMJ. 2018 Dec 4;363:k4893. doi: 10.1136/bmj.k4893.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2009
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: October 25, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimated): October 27, 2009

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise therapy; Arthroscopy; Degenerative meniscal tear
• Other Study ID Numbers: NARSDU2009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO