Tear of Meniscus of KneeDREAMNCT02995551
Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults
A study testing Arthroscopic meniscal repair or resection and Exercise and education in people with Tear of Meniscus of Knee, run by University of Southern Denmark at 7 sites in Denmark.
Trial summary
There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can be caused by either a smaller or larger trauma or be a degenerative age-related tear. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tear of Meniscus of Knee
- What is being tested?
- Arthroscopic meniscal repair or resection and Exercise and education
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 7 sitesDenmark
- Study dates
- Jan 2017to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 40 years with knee pain
- 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
Who cannot join
- Previous knee surgery on the affected knee
- 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.)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Department of Orthopedic Surgery, Aalborg University Hospital
Aalborg
Department of Sports Traumatology, Aarhus University Hospital
Aarhus
Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre
Copenhagen
Department of Orthopedic Surgery, Lillebælt Hospital in Kolding
Kolding
Department of Orthopedic Surgery, Næstved Hospital
Næstved
Department of Orthopedics and Traumatology, Odense University Hospital
Odense
Elective Surgery Centre, Regionshospitalet Silkeborg
Silkeborg
About this study
Official title: Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) - A Randomized Controlled Trial of Meniscal Tear Treatment in Young Adults
There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can be caused by either a smaller or larger trauma or be a degenerative age-related tear. Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40 years or younger) in comparison to non-surgical treatments.
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.
Read the detailed description
Arthroscopic meniscal surgery is the most common orthopedic procedure. In Denmark, meniscal surgeries have doubled from around 9.000 yearly procedures in 2000 to more than 17.000 in 2011, with the total number of meniscal surgeries exceeding 150.000 in this period. Similar trends have been observed in the US, where more than 700.000 orthopedic procedures are carried out annually. Numerous randomized controlled trials (RCT) have investigated the efficacy of meniscal surgery compared with placebo surgery, in addition to non-surgical treatment and in direct comparison to exercise in middle-aged and older patients.
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):
- 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.
- 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
- Tear of Meniscus of Knee
- Being tested
- Arthroscopic meniscal repair or resection, Exercise and education
- Keywords
- Menisci, Tibial, Knee Injuries, Arthroscopy, Exercise, Young adults, Treatment Outcome, Humans
- Medical subject headings
- Knee Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic meniscal repair or resectionProcedure or surgery
Arthroscopic meniscal repair or resection following standard procedures.
Exercise and educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopy | Experimental | 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). Receives: Procedure: Arthroscopic meniscal repair or resection |
| Exercise and Education | Active comparator | 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. Receives: Behavioral: Exercise and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Knee Injury and Osteoarthritis Outcome Score (KOOS4)
The mean score for the KOOS subscales Pain, Symptoms, Function in sports and recreational activities, and Quality of life. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.
Measured: Primary endpoint: Change from baseline to 12 months.
Secondary outcomes (8)
The five KOOS subscales
To allow for clinical in-depth interpretation, the primary outcome will be complemented by subscale scores from each of the five individual KOOS subscales. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.
Measured: Primary endpoint: Change from baseline to 12 months.
Western Ontario Meniscal Evaluation Tool (WOMET)
WOMET is a meniscus specific patient-reported outcome measure that will be used to complement the KOOS score. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.
Measured: Primary endpoint: Change from baseline to 12 months.
Isometric muscle strength
Isometric muscle strength will be assessed using the FysioMeter. Assessed at baseline, 3 and 12 months.
Measured: Primary endpoint: Change from baseline to 3 months.
The maximum number of knee-bends in 30s
The maximum number of knee-bends in 30s is one of three measures of functional performance. All visits (baseline, 3, 6 and 12 months) will be included in the analysis.
Measured: Primary endpoint: Change from baseline to 12 months.
The one-leg hop for distance
The one-leg hop for distance is one of three measures of functional performance. Assessed only at 12 months.
Measured: Primary endpoint: 12 months.
The 6 m timed hop
The 6 m timed hop is one of three measures of functional performance. Assessed only at 12 months.
Measured: Primary endpoint: 12 months.
Adverse events
Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. Furthermore, the medical records from the participating hospitals will be checked at the primary endpoint (12 months) for all AEs occurring from inclusion until the 12 months follow-up. AEs will be categorized into index knee or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments. Assessed at 3, 6 and 12 months. Will also be assessed after 24 months.
Measured: Primary endpoint: 12 months.
Structural knee joint changes
Structural knee joint changes from baseline to 24 months will be assessed using the Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS).
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionFeb 2021
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tear of Meniscus of KneeStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Hvidovre, Aalborg University Hospital, Sygehus Lillebaelt, Naestved Hospital, Odense University Hospital, Slagelse Hospital, Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, The Danish Rheumatism Association, Spar Nord Foundation, Association of Danish Physiotherapists, Regionshospitalet Silkeborg
- Responsible party
- Principal investigator, Søren Thorgaard Skou, University of Southern Denmark
- Investigators
- Søren T. Skou, PT, PhD, Principal investigator, University of Southern Denmark and Næstved-Slagelse-Ringsted HospitalsJonas B Thorlund, MSc, PhD, Study chair, University of Southern DenmarkMartin Lind, Prof, MD, PhD, DMSc, Study chair, Aarhus University HospitalPer Hölmich, Prof, MD, DMSc, Study chair, Copenhagen University Hospital, Amager-HvidovreHans P Jensen, MD, Study chair, Aalborg University HospitalCarsten Jensen, MSc, PhD, Study chair, Lillebælt Hospital in KoldingMuhammad Afzal, MD, Study chair, Naestved HospitalUffe Jørgensen, Prof, MD, DMSc, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995551
- Sponsor's protocol ID
- S-20160151
- Other IDs
- DFF - 6110-00045
- Acronym
- DREAM
- Status last verified
- Jan 2022
- First submitted
- 8 Dec 2016
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 38319181Clausen 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.
PubMed 37879858Damsted 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.
PubMed 36878666Skou 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.
PubMed 28827270
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) - A Randomized Controlled Trial of Meniscal Tear Treatment in Young Adults
- ClinicalTrials.gov ID
- NCT02995551
- Acronym / sponsor ID
- DREAM / S-20160151
- Conditions
- Tear of Meniscus of Knee
- Keywords
- Menisci, Tibial, Knee Injuries, Arthroscopy, Exercise, Young adults, Treatment Outcome, Humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Hvidovre, Aalborg University Hospital, Sygehus Lillebaelt, Naestved Hospital, Odense University Hospital, Slagelse Hospital, Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, The Danish Rheumatism Association, Spar Nord Foundation, Association of Danish Physiotherapists, Regionshospitalet Silkeborg
- Study start
- Jan 2017 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can be caused by either a smaller or larger trauma or be a degenerative age-related tear. Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40 years or younger) in comparison to non-surgical treatments.
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.
Detailed description
Arthroscopic meniscal surgery is the most common orthopedic procedure. In Denmark, meniscal surgeries have doubled from around 9.000 yearly procedures in 2000 to more than 17.000 in 2011, with the total number of meniscal surgeries exceeding 150.000 in this period. Similar trends have been observed in the US, where more than 700.000 orthopedic procedures are carried out annually. Numerous randomized controlled trials (RCT) have investigated the efficacy of meniscal surgery compared with placebo surgery, in addition to non-surgical treatment and in direct comparison to exercise in middle-aged and older patients.
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):
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopy | Experimental | Procedure: Arthroscopic meniscal repair or resectionArthroscopic 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). |
| Exercise and Education | Active comparator | Behavioral: Exercise and educationPatients 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 40 years with knee pain
- 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
Key exclusion criteria (6 listed)
- Previous knee surgery on the affected knee
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic meniscal repair or resectionArthroscopic meniscal repair or resection following standard procedures. | Procedure or surgery | Arthroscopy |
| Exercise and educationA 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. | Behavioural | Exercise and Education |
Primary outcome
the Knee Injury and Osteoarthritis Outcome Score (KOOS4)
Time frame: Primary endpoint: Change from baseline to 12 months.
The mean score for the KOOS subscales Pain, Symptoms, Function in sports and recreational activities, and Quality of life. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months.
8 secondary outcomes
The five KOOS subscales
Time frame: Primary endpoint: Change from baseline to 12 months.
Western Ontario Meniscal Evaluation Tool (WOMET)
Time frame: Primary endpoint: Change from baseline to 12 months.
Isometric muscle strength
Time frame: Primary endpoint: Change from baseline to 3 months.
The maximum number of knee-bends in 30s
Time frame: Primary endpoint: Change from baseline to 12 months.
The one-leg hop for distance
Time frame: Primary endpoint: 12 months.
The 6 m timed hop
Time frame: Primary endpoint: 12 months.
Adverse events
Time frame: Primary endpoint: 12 months.
Structural knee joint changes
Time frame: Baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 38319181Skou 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.
- Derived from this study: PubMed 37879858Clausen 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.
- Derived from this study: PubMed 36878666Damsted 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.
- Derived from this study: PubMed 28827270Skou 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.
- Individual participant dataSharing planned: No
Related trials for Tear of Meniscus of Knee
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Recruiting
Novel Bioactive Sleeve on Pain and PROMs
Meniscus Tear
Active, not recruitingPhase 3
Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
Recruiting
This is a Study to Verify if Marrow Venting Procedure Can Improve Meniscal Suture Healing
Meniscal Tear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren T. Skou, PT, PhD principal investigator
University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals
Jonas B Thorlund, MSc, PhD study chair
University of Southern Denmark
Martin Lind, Prof, MD, PhD, DMSc study chair
Aarhus University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic meniscal repair or resection and Exercise and education in people with Tear of Meniscus of Knee, run by University of Southern Denmark at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Knee Injury and Osteoarthritis Outcome Score (KOOS4) (time frame: Primary endpoint: Change from baseline to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995551, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.