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Completed

NCT Number: NCT01002794

Surgical or Exercise Therapy on Patients With Degenerative Meniscus Tears

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).

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Key information

Conditions

Degenerative Meniscal Tear

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Department, Oslo University Hospital, Ullevaal

Oslo, 0450, Norway

About this study

The aims of the study are:

  • 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.
  • 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.
  • 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. 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic partial menisectomy

Procedure

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

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

Primary outcomes

  1. KOOS4 - Change From Baseline

    Time frame: 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).

  2. Peak Torque Knee Extension - Change From Baseline

    Time frame: at 3 months

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

  3. Peak Torque Knee Flexion - Change From Baseline

    Time frame: 3 months

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

  4. Knee Osteoarthritis Incidence

    Time frame: 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.

  5. Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years]

    Time frame: 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]

Secondary outcomes

  1. One Leg Hop Test - Change From Baseline

    Time frame: 3 months

    Change in distance (meters) hopped on the One leg hop test from baseline to three months (higher is better).

  2. 6 Meter Timed Hop Test - Change From Baseline

    Time frame: 3 months

    Change in time (seconds) on the 6 meter timed hop test from baseline to 3 months (lower is better)

  3. Knee Bends 30 Sec - Change From Baseline

    Time frame: 3 months

    Change in number of repetitions performed on the Knee bends 30 seconds test from baseline to 3 months (higher is better).

  4. Peak Torque Knee Extension - Change From Baseline

    Time frame: 1 year

    Change in Peak torque knee extension (Newton meter) from baseline to 12 months (higher is better).

  5. Peak Torque Knee Flexion - Change From Baseline

    Time frame: 12 months

    Change in Peak torque knee flexion (Newton meter) from baseline to 12 months (higher is better).

  6. One-leg Hop Test - Change in From Baseline

    Time frame: 12 months

    Change in distance (meters) hopped on the One leg hop test from baseline to 12 months (higher is better).

  7. 6 Meter Timed Hop Test - Change From Baseline

    Time frame: 12 months

    Change in time (seconds) on the 6 meter timed hop test from baseline to 12 months (lower is better).

  8. Knee Bends 30 Sec - Change From Baseline

    Time frame: 12 months

    Change in number of repetitions performed on the Knee bends 30 seconds test from baseline to 12 months (higher is better).

  9. KOOS Pain - Change From Baseline

    Time frame: 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.

  10. KOOS Symptoms - Change From Baseline

    Time frame: 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.

  11. KOOS ADL - Change From Baseline

    Time frame: 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

  12. KOOS Sport/Rec - Change From Baseline

    Time frame: 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.

  13. KOOS QOL - Change From Baseline

    Time frame: 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.

  14. SF-36 MCS - Change From Baseline

    Time frame: 24 months

    Change in Short form 36 mental component summary (SF-36 MCS) from baseline to 24 months (range: 0-100; higher is better)

  15. SF-36 PCS - Change From Baseline

    Time frame: 24 months

    Change in Short form 36 physical component summary (SF-36 PCS) from baseline to 24 months (range: 0-100; higher is better)

  16. KOOS Pain Subscale - Change From Baseline

    Time frame: 5 years

    Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale from baseline to five years (range: 0-100; higher is better).

  17. KOOS Symptoms Subscale - Change From Baseline

    Time frame: 5 years

    Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms subscale from baseline to five years (range: 0-100; higher is better).

  18. KOOS ADL Subscale - Change From Baseline

    Time frame: 5 years

    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).

  19. KOOS Sport/Rec Subscale - Change From Baseline

    Time frame: 5 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).

  20. KOOS QOL Subscale - Change From Baseline

    Time frame: 5 years

    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).

  21. Peak Torque Knee Extension - Change From Baseline

    Time frame: 5 years

    Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to five years (higher is better).

  22. Peak Torque Knee Flexion - Change From Baseline

    Time frame: 5 years

    Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to five years (higher is better).

  23. Knee Osteoarthritis Incidence (Kellgren and Lawrence Classification )

    Time frame: 10 years

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

  24. KOOS4 - Change From Baseline

    Time frame: 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).

  25. KOOS Pain Subscale - Change From Baseline

    Time frame: 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).

  26. KOOS Symptoms Subscale - Change From Baseline

    Time frame: 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).

  27. KOOS ADL Subscale - Change From Baseline

    Time frame: 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).

  28. KOOS Sport/Rec Subscale - Change From Baseline

    Time frame: 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).

  29. KOOS QOL Subscale - Change From Baseline

    Time frame: 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).

  30. Peak Torque Knee Flexion - Change From Baseline

    Time frame: 10 years

    Change in body weight (kilograms) normalized Peak torque knee flexion (Newton meter/kg) from baseline to ten years (higher is better).

  31. Peak Torque Knee Extension - Change From Baseline

    Time frame: 10 years

    Change in body weight (kilograms) normalized Peak torque knee extension (Newton meter/kg) from baseline to 10 years (higher is better).

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • South-Eastern Norway Regional Health Authority
  • University of Southern Denmark

Registry information

Official study title

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

Acronym: OMEX

Important dates

Study start
2009
Primary completion
2016
Study completion
2024
First posted
Oct 27, 2009
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.