Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults
NCT ID: NCT02995551
Last Updated: 2022-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2017-01-31
2022-02-28
Brief Summary
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The purpose of this study is to determine if a strategy of early arthroscopic meniscal surgery (repair or resection) is superior to a strategy of initial individualized supervised exercise therapy including patient education with the option of later surgery if needed in improving pain, function and quality of life in young patients (18-40 years) with meniscal tears.
The hypothesis is that patients treated with early arthroscopic meniscal surgery will improve more than patients treated with exercise and education.
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Detailed Description
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However, no RCTs have investigated the efficacy of meniscal surgery for younger patients (i.e. 40 years or younger) in comparison to non-surgical treatments. In contrast to middle-aged and older adults with degenerative meniscal tears of unknown origin, most tears in younger adults (18-40 years) are of traumatic origin (i.e. such as a sports related trauma), which highlights the need for a high-quality trial in the younger population.
The aim of this RCT is to investigate if early arthroscopic meniscal surgery (repair or resection) is superior to individualized supervised exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in young patients (18-40 years) with meniscal tears. The study hypothesis is that patients randomized to surgery will improve significantly more in pain, function and quality of life after 12 months than those randomized to exercise and education.
Patients fulfilling eligibility criteria and willing to participate in the study will be randomized to one of the two groups after the baseline assessment with follow-up after 3, 6 and 12 months (Subsequently, a 24-month follow-up has been added):
1. Arthroscopic meniscal surgery: Arthroscopic meniscal repair or resection will be conducted at the discretion of the operating surgeon (this cannot be determined before the surgeon has visual confirmation about the exact knee pathology and extend of the meniscal tear by scope).
After surgery, patients will receive the standard rehabilitation in the postoperative period depending of type of surgery, since this differs for patients who have had resection and repair. A standard folder with exercises will be given to those having a partial meniscectomy to ensure a minimum level of rehabilitation after the surgery across the hospitals.
2. Exercise therapy and patient education: Patients allocated to exercise therapy and education will participate in a 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear. Furthermore, they will participate in a patient education program developed through interviews with pilot study participants, from our experiences from the Good Life with osteoArthritis in Denmark (GLA:D) program for patients with knee and hip pain. Both the exercise and education will take place in a number of private physiotherapy clinics associated with the GLA:D program, specifically trained to supervise and lead the treatment in this study. A similar exercise program and educational program have been shown to be effective in improving pain, function and quality of life in patients with other types of knee injuries and knee pain.
Observational cohort:
Patients fulfilling all eligibility but unwilling to participate in the randomized study and patients 18-40 years of age with a clinical history and symptoms consistent with a meniscal tear that does not fulfill the other criteria are asked to participate in an observational cohort with the same questionnaires as in the RCT, but following usual clinical practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arthroscopy
Arthroscopic meniscal repair or resection will be conducted at the discretion of the operating surgeon (this cannot be determined before the surgeon has visual confirmation about the exact knee pathology and extend of the meniscal tear by scope).
Arthroscopic meniscal repair or resection
Arthroscopic meniscal repair or resection following standard procedures.
Exercise and Education
Patients allocated to exercise therapy and education will participate in a 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear. Furthermore, they will participate in a patient education program developed through interviews with pilot study participants, from our experiences from the Good Life with osteoArthritis in Denmark (GLA:D) program for patients with knee and hip pain. Both the exercise and education will take place in a number of private physiotherapy clinics associated with the GLA:D program, specifically trained to supervise and lead the treatment in this study.
Exercise and education
A 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear combined with patient education teaching the participants about their disease and how to manage it through exercise and in their daily life.
Interventions
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Arthroscopic meniscal repair or resection
Arthroscopic meniscal repair or resection following standard procedures.
Exercise and education
A 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear combined with patient education teaching the participants about their disease and how to manage it through exercise and in their daily life.
Eligibility Criteria
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Inclusion Criteria
* Clinical history and symptoms consistent with meniscal tear and meniscal tear verified on magnetic resonance imaging (MRI)
* Deemed eligible for meniscal surgery (i.e. repair or resection) by the examining orthopedic surgeon
* Willing to participate in 12 weeks of supervised exercise twice a week or undergo surgery for the meniscal tear as soon as possible
Exclusion Criteria
* Clinical suspicion (acute locking of knee AND/OR extension deficit) of displaced bucket-handle tear confirmed by MRI
* Fracture of the affected extremity within the previous 12 months
* Complete rupture of one or more knee ligaments.
* Participation in supervised systematic exercise for knee problems within the last 3 months prior to recruitment
* Other reasons for exclusion (Unable to understand Danish, mentally unable to participate, etc.)
18 Years
40 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Copenhagen University Hospital, Hvidovre
OTHER
Aalborg University Hospital
OTHER
Sygehus Lillebaelt
OTHER
Naestved Hospital
OTHER
Odense University Hospital
OTHER
Slagelse Hospital
OTHER
Danish Council for Independent Research
OTHER
IMK Almene Fond
OTHER
Lundbeck Foundation
OTHER
The Danish Rheumatism Association
OTHER
Spar Nord Foundation
UNKNOWN
Association of Danish Physiotherapists
OTHER
Regionshospitalet Silkeborg
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Søren Thorgaard Skou
PT, PhD, Professor
Principal Investigators
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Søren T. Skou, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals
Jonas B Thorlund, MSc, PhD
Role: STUDY_CHAIR
University of Southern Denmark
Martin Lind, Prof, MD, PhD, DMSc
Role: STUDY_CHAIR
Aarhus University Hospital
Per Hölmich, Prof, MD, DMSc
Role: STUDY_CHAIR
Copenhagen University Hospital, Amager-Hvidovre
Hans P Jensen, MD
Role: STUDY_CHAIR
Aalborg University Hospital
Carsten Jensen, MSc, PhD
Role: STUDY_CHAIR
Lillebælt Hospital in Kolding
Muhammad Afzal, MD
Role: STUDY_CHAIR
Naestved Hospital
Uffe Jørgensen, Prof, MD, DMSc
Role: STUDY_CHAIR
Odense University Hospital
Mogens Strange Hansen, MD, PhD
Role: STUDY_CHAIR
Elective Surgery Centre, Regionshospitalet Silkeborg
Locations
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Department of Orthopedic Surgery, Aalborg University Hospital
Aalborg, , Denmark
Department of Sports Traumatology, Aarhus University Hospital
Aarhus, , Denmark
Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre
Copenhagen, , Denmark
Department of Orthopedic Surgery, Lillebælt Hospital in Kolding
Kolding, , Denmark
Department of Orthopedic Surgery, Næstved Hospital
Næstved, , Denmark
Department of Orthopedics and Traumatology, Odense University Hospital
Odense, , Denmark
Elective Surgery Centre, Regionshospitalet Silkeborg
Silkeborg, , Denmark
Countries
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References
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Skou ST, Holmich P, Lind M, Jensen HP, Jensen C, Garval M, Thorlund JB. Early Surgery or Exercise and Education for Meniscal Tears in Young Adults. NEJM Evid. 2022 Feb;1(2):EVIDoa2100038. doi: 10.1056/EVIDoa2100038. Epub 2022 Jan 25.
Clausen SH, Skou ST, Boesen MP, Radev DI, Kurt EY, Damsted C, Holmich P, Lind M, Torring S, Isaksen C, Varnum C, Englund M, Thorlund JB. Two-year MRI-defined structural damage and patient-reported outcomes following surgery or exercise for meniscal tears in young adults. Br J Sports Med. 2023 Nov 30;57(24):1566-1572. doi: 10.1136/bjsports-2023-107352.
Damsted C, Thorlund JB, Holmich P, Lind M, Varnum C, Villumsen MD, Hansen MS, Skou ST. Effect of exercise therapy versus surgery on mechanical symptoms in young patients with a meniscal tear: a secondary analysis of the DREAM trial. Br J Sports Med. 2023 May;57(9):521-527. doi: 10.1136/bjsports-2022-106207. Epub 2023 Mar 6.
Skou ST, Lind M, Holmich P, Jensen HP, Jensen C, Afzal M, Jorgensen U, Thorlund JB. Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults. BMJ Open. 2017 Aug 21;7(8):e017436. doi: 10.1136/bmjopen-2017-017436.
Other Identifiers
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DFF - 6110-00045
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
S-20160151
Identifier Type: -
Identifier Source: org_study_id
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