Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

Oslo University Hospital140 enrolled

Overview

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).

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

Allocation

Conditions

Degenerative Meniscal Tear

Interventions

Arthroscopic partial menisectomyPROCEDURE

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

Supervised neuromuscular and strength trainingOTHER

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Orthopaedic Department, Oslo University Hospital, Ullevaal

Oslo, Norway

Outcomes

Primary Outcomes

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).

Time frame: 24 months

Peak Torque Knee Extension - Change From Baseline

Peak torque knee extension (Newton meter) - Change from baseline

Time frame: at 3 months

Peak Torque Knee Flexion - Change From Baseline

Peak torque knee flexion (Newton meter) - Change from baseline

Time frame: 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.

Time frame: 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) \[Time Frame: At 10 years\]

Data from ClinicalTrials.gov

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Secondary Outcomes

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).

Time frame: 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)

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 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)

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 5 years

Knee Osteoarthritis Incidence (Kellgren and Lawrence Classification )

Knee osteoarthritis incidence (Kellgren and Lawrence classification) \[ Time Frame: 10 years\]

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 10 years