Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

NCT01002794 | Completed Results

• 1 other identifier: NARSDU2009
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Degenerative Meniscal Tear

Keywords

Degenerative meniscal tear; Arthroscopy; Exercise therapy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (31)

• One Leg Hop Test - Change From Baseline

  3 months

• 6 Meter Timed Hop Test - Change From Baseline

  3 months

• Knee Bends 30 Sec - Change From Baseline

  3 months

• Peak Torque Knee Extension - Change From Baseline

  1 year

• Peak Torque Knee Flexion - Change From Baseline

  12 months

Study Arms (2)

Arthroscopic partial meniscectomy

EXPERIMENTAL

Standard arthroscopic partial meniscectomy - NGD 1

Procedure: Arthroscopic partial menisectomy

Exercise Therapy

EXPERIMENTAL

Supervised neuromuscular- and strength training

Other: Supervised neuromuscular and strength training

Interventions

Arthroscopic partial menisectomy PROCEDURE

Standard arthroscopic partial meniscectomy, NGD 1. Carried out at Ullevaal University Hospital and Martina Hansens Hospital.

Arthroscopic partial meniscectomy

Supervised neuromuscular and strength training OTHER

Supervised exercise therapy in 12 weeks, both neuromuscular- and strength training. Carried out at Nimi Ullevaal Oslo or Gnist trending- og fysioterapi, Baerum

Exercise Therapy

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Southern Denmark: collaborator
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Orthopaedic Department, Oslo University Hospital, Ullevaal

Oslo, 0450, Norway

Location

Related Publications (10)

• 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.

  PMID: 25299520 BACKGROUND

• 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.

  PMID: 30446783 BACKGROUND

• 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.

  PMID: 31298923 BACKGROUND

• 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.

  PMID: 33971735 BACKGROUND

• 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.

  PMID: 27440192 RESULT

• 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.

  PMID: 32184135 RESULT

• 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.

  PMID: 34151533 RESULT

• Berg B, Roos EM, Englund M, Kise NJ, Engebretsen L, Eftang CN, Risberg MA. Arthroscopic partial meniscectomy versus exercise therapy for degenerative meniscal tears: 10-year follow-up of the OMEX randomised controlled trial. Br J Sports Med. 2025 Jan 2;59(2):91-98. doi: 10.1136/bjsports-2024-108644.

  PMID: 39326908 DERIVED

• 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.

  PMID: 30142084 DERIVED

• 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.

  PMID: 22960783 DERIVED

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Professor May Arna Risberg
• Organization: Oslo University Hospital

marisb@ous-hf.no

+4741312776

Study Officials

• May Arna Risberg, PT, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2009
• First Posted: October 27, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2016
• Study Completion: January 1, 2024
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)