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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Kuopio University Hospital | OTHER |
| Turku University Hospital | OTHER_GOV |
| Central Finland Hospital District |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative (O) | Active Comparator | Partial resection of degenerative tear of medial meniscus |
|
| Conservative (K) | Sham Comparator | Arthroscopy (diagnostic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operative (partial arthroscopy) | Procedure | Partial arthroscopic resection of degenerative rupture of the medial meniscus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year |
| 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. | One year |
| 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. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | One year |
| Pain at Rest (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teppo LN Jarvinen, MD, PhD | Tampere University | Study Chair |
| Raine TA Sihvonen, MD | Tampere City Hospital | Principal Investigator |
| Mika Paavola, MD, PhD | University of Helsinki | Study Director |
| Antti Malmivaara, MD, PhD | University of Helsinki | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki Central Hospital | Helsinki | Finland | ||||
| Central Finland Hospital District |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39277028 | Derived | Sillanpaa N, Iivanainen M, Turkiewicz A, Sihvonen R, Paavola M, Taimela S, Jarvinen TLN, Englund M. Effect of arthroscopic partial meniscectomy on structural degeneration of the knee - A 5-year MRI-based follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Osteoarthritis Cartilage. 2025 Feb;33(2):276-282. doi: 10.1016/j.joca.2024.09.003. Epub 2024 Sep 12. | |
| 38905520 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Conservative (K) | Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy n=76 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Age, Sex, Weight, Height, BMI, Duration of medial knee pain, Type of onset of symptoms, Radiographic assessment (Kellfren-Lawrence), Clinical meniscal tests
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Conservative (K) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | One year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Operative (O) | Partial resection of degenerative tear of medial meniscus Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious adverse event | Infections and infestations | A deep infection of the index knee 4 months after surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Teppo Järvinen, Head of study chair | University of Helsinki | teppo.jarvinen@helsinki.fi |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| OTHER |
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| Conservative (diagnostic arthroscopy) | Procedure | Diagnostic arthroscopy |
|
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. |
| One year |
| Cost Effectiveness | Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence. | 1 and 2 years |
| Jyväskylä |
| Finland |
| Kuopio University Hospital | Kuopio | Finland |
| Hatanpää City Hospital | Tampere | FI-33101 | Finland |
| Turku University Hospital | Turku | Finland |
| Derived |
| Kalske R, Kiadaliri A, Sihvonen R, Englund M, Turkiewicz A, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Toivonen P, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscal Lesion Study) Investigators. Arthroscopic Partial Meniscectomy for a Degenerative Meniscus Tear Is Not Cost Effective Compared With Placebo Surgery: An Economic Evaluation Based on the FIDELITY Trial Data. Clin Orthop Relat Res. 2024 Sep 1;482(9):1523-1533. doi: 10.1097/CORR.0000000000003094. Epub 2024 May 7. |
| 32855201 | Derived | Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Kalske J, Nurmi H, Kumm J, Sillanpaa N, Kiekara T, Turkiewicz A, Toivonen P, Englund M, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscus Lesion Study) Investigators. Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Br J Sports Med. 2020 Nov;54(22):1332-1339. doi: 10.1136/bjsports-2020-102813. Epub 2020 Aug 27. |
| 31937344 | Derived | Sihvonen R, Kalske R, Englund M, Turkiewicz A, Toivonen P, Taimela S, Jarvinen TLN; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Investigators. Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial. Trials. 2020 Jan 14;21(1):76. doi: 10.1186/s13063-019-3833-2. |
| 26856620 | Derived | Sihvonen R, Englund M, Turkiewicz A, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study Group. Mechanical Symptoms and Arthroscopic Partial Meniscectomy in Patients With Degenerative Meniscus Tear: A Secondary Analysis of a Randomized Trial. Ann Intern Med. 2016 Apr 5;164(7):449-55. doi: 10.7326/M15-0899. Epub 2016 Feb 9. |
| 24369076 | Derived | Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189. |
| 23474796 | Derived | Sihvonen R, Paavola M, Malmivaara A, Jarvinen TL. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design. BMJ Open. 2013 Mar 9;3(3):e002510. doi: 10.1136/bmjopen-2012-002510. |
Arthroscopy (diagnostic)
Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
n=76
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | One year |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | One year |
|
|
|
| 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). | Posted | Mean | 95% Confidence Interval | units on a scale | One year |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | One year |
|
|
|
| Secondary | Cost Effectiveness | Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence. | Not Posted | Nov 2023 | 1 and 2 years | Participants |
| 1 |
| 70 |
| 0 |
| 70 |
| EG001 | Conservative (K) | Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy | 0 | 76 | 0 | 76 |
|
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| D012216 |
| Rheumatic Diseases |