Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

Not Applicable

Completed

Conditions: Degenerative Meniscal Tear

Interventions: Procedure: Arthroscopic partial menisectomy
Other: Supervised neuromuscular and strength training

Registration Number: NCT01002794

Lead Sponsor: Oslo University Hospital

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic partial meniscectomy	Arthroscopic partial menisectomy	Standard arthroscopic partial meniscectomy - NGD 1
Exercise Therapy	Supervised neuromuscular and strength training	Supervised neuromuscular- and strength training

Primary Outcome Measures

Name	Time	Method
KOOS4 - Change From Baseline	24 months	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).
Peak Torque Knee Extension - Change From Baseline	at 3 months	Peak torque knee extension (Newton meter) - Change from baseline
Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years]	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) \[Time Frame: At 10 years\]
Peak Torque Knee Flexion - Change From Baseline	3 months	Peak torque knee flexion (Newton meter) - Change from baseline
Knee Osteoarthritis Incidence	5 years	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.

Secondary Outcome Measures

Name	Time	Method
One Leg Hop Test - Change From Baseline	3 months	Change in distance (meters) hopped on the One leg hop test from baseline to three months (higher is better).
SF-36 PCS - Change From Baseline	24 months	Change in Short form 36 physical component summary (SF-36 PCS) from baseline to 24 months (range: 0-100; higher is better)
Knee Bends 30 Sec - Change From Baseline	12 months	Change in number of repetitions performed on the Knee bends 30 seconds test from baseline to 12 months (higher is better).
6 Meter Timed Hop Test - Change From Baseline	12 months	Change in time (seconds) on the 6 meter timed hop test from baseline to 12 months (lower is better).
Peak Torque Knee Flexion - Change From Baseline	10 years	Change in body weight (kilograms) normalized Peak torque knee flexion (Newton meter/kg) from baseline to ten years (higher is better).
KOOS Sport/Rec - Change From Baseline	24 months	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.
One-leg Hop Test - Change in From Baseline	12 months	Change in distance (meters) hopped on the One leg hop test from baseline to 12 months (higher is better).
KOOS ADL - Change From Baseline	24 months	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
SF-36 MCS - Change From Baseline	24 months	Change in Short form 36 mental component summary (SF-36 MCS) from baseline to 24 months (range: 0-100; higher is better)
Knee Osteoarthritis Incidence (Kellgren and Lawrence Classification )	10 years	Knee osteoarthritis incidence (Kellgren and Lawrence classification) \[ Time Frame: 10 years\]
Peak Torque Knee Extension - Change From Baseline	10 years	Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to 10 years (higher is better).
KOOS Pain - Change From Baseline	24 months	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.
KOOS Symptoms - Change From Baseline	24 months	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.
KOOS ADL Subscale - Change From Baseline	10 years	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).
KOOS Sport/Rec Subscale - Change From Baseline	10 years	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).
KOOS4 - Change From Baseline	10 years	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).
KOOS QOL - Change From Baseline	24 months	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.
KOOS Pain Subscale - Change From Baseline	10 years	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to 10 years (range: 0-100; higher is better).
KOOS Symptoms Subscale - Change From Baseline	10 years	Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to 10 years (range: 0-100; higher is better).
KOOS QOL Subscale - Change From Baseline	10 years	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).