Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee, Arthroscopic Surgery, Menisci, Medial, Placebo Effect, Treatment Efficacy
Brief summary
Degenerative meniscal tears are the most common etiology for knee pain, swelling and loss of function. Partial arthroscopic meniscectomy is the most common orthopaedic procedure to treat meniscal tears. Improvements have been reported both after arthroscopy and with conservative treatment, however no direct comparison exist. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial.
Detailed description
Middle-aged men and women with degenerative meniscal tears constitute a large group of patients presenting with knee pain, sometimes accompanied with swelling and loss of function. Many meniscal tears occur without a trauma in physically active individuals as well as in older people and could be a part of early osteoarthritis. Partial arthroscopic meniscectomy is the most common orthopaedic procedure and is used to treat patients with meniscal tears. Many patients report improvement after arthroscopy referring especially to reduced knee pain, better knee function and improved quality of life. However, similar results have also been obtained with conservative treatment (physical therapy) of patients with degenerative meniscal tears. Accordingly, the aim of this study is to assess the efficacy of arthroscopic partial meniscectomy for the treatment of degenerative tear of medial meniscus of the knee using a double-blind, placebo controlled, randomised trial. The outcome of arthroscopic partial meniscectomy (vs. sham surgery) is assessed using the Lysholm knee score and pain at rest and activity (VAS) at 2, 6 and 12 months after the operation. In addition, the functional outcome is assessed using the WOMET knee score (a disease-specific quality of life -knee score development on the assessment of meniscal pathology), the general quality of life score (15-D), and cost-effectiveness analysis.
Interventions
PROCEDUREOperative (partial arthroscopy)
Partial arthroscopic resection of degenerative rupture of the medial meniscus
PROCEDUREConservative (diagnostic arthroscopy)
Diagnostic arthroscopy
Sponsors
Helsinki University Central Hospital
Kuopio University Hospital
Turku University Hospital
Central Finland Hospital District
Tampere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: 35 to 65 years of age. 2. A pain located on the medial joint line of the knee that has persistent at least for 3 months. 3. Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign. 4. Tear of the medial meniscus on MRI. 5. Degenerative rupture of the medial meniscus confirmed at arthroscopy.
Exclusion criteria
1. Acute, trauma-induced onset of symptoms. 2. Locking or painful snapping of the knee joint. 3. A surgical operation performed on the affected knee. 4. Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR). 5. Osteoarthritis on knee radiographs (Kellgren-Lawrence \> 1). 6. Acute (within the previous year) fractures of the knee. 7. Decreased range of motion of the knee. 8. Instability of the knee. 9. MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment. 10. Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Lysholm Knee Score | One year | The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms. |
| Pain After Exercise (VAS) | One year | Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain. |
| WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) | One year | The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 15-D (General Quality of Life -Assessment Tool) | One year | The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death). |
| Pain at Rest (VAS) | One year | Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain. |
| Cost Effectiveness | 1 and 2 years | Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence. |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Operative (O) Partial resection of degenerative tear of medial meniscus
Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus
n=70 | 70 |
| Conservative (K) Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
n=76 | 76 |
| Total | 146 |
Baseline characteristics
| Characteristic | Operative (O) | Conservative (K) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 76 Participants | 146 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 7 | 52 years STANDARD_DEVIATION 7 | 52 years STANDARD_DEVIATION 7 |
| Region of Enrollment Finland | 70 participants | 76 participants | 146 participants |
| Sex: Female, Male Female | 28 Participants | 29 Participants | 57 Participants |
| Sex: Female, Male Male | 42 Participants | 47 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 76 |
| serious Total, serious adverse events | 1 / 70 | 0 / 76 |
Outcome results
Primary
Pain After Exercise (VAS)
Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
Time frame: One year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Operative (O) | Pain After Exercise (VAS) | 2.7 units on a scale |
| Conservative (K) | Pain After Exercise (VAS) | 2.9 units on a scale |
Primary
The Lysholm Knee Score
The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.
Time frame: One year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Operative (O) | The Lysholm Knee Score | 82.2 units on a scale |
| Conservative (K) | The Lysholm Knee Score | 83.4 units on a scale |
Primary
WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)
The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.
Time frame: One year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Operative (O) | WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) | 81.0 units on a scale |
| Conservative (K) | WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool) | 79.9 units on a scale |
Secondary
15-D (General Quality of Life -Assessment Tool)
The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).
Time frame: One year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Operative (O) | 15-D (General Quality of Life -Assessment Tool) | 0.94 units on a scale |
| Conservative (K) | 15-D (General Quality of Life -Assessment Tool) | 0.92 units on a scale |
Secondary
Cost Effectiveness
Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.
Time frame: 1 and 2 years
Secondary
Pain at Rest (VAS)
Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
Time frame: One year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Operative (O) | Pain at Rest (VAS) | 1.6 units on a scale |
| Conservative (K) | Pain at Rest (VAS) | 1.9 units on a scale |