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Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults (DREAM)

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ClinicalTrials.gov Identifier: NCT02995551
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : June 4, 2019
Sponsor:
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
Information provided by (Responsible Party):
Søren Thorgaard Skou, University of Southern Denmark

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Tear of Meniscus of Knee Procedure: Arthroscopic meniscal repair or resection Behavioral: Exercise and education Not Applicable

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.

  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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Procedure: Arthroscopic meniscal repair or resection
Arthroscopic meniscal repair or resection following standard procedures.

Active Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The five KOOS subscales [ Time Frame: Primary endpoint: Change from baseline to 12 months. ]
    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.

  2. Western Ontario Meniscal Evaluation Tool (WOMET) [ Time Frame: Primary endpoint: Change from baseline to 12 months. ]
    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.

  3. Isometric muscle strength [ Time Frame: Primary endpoint: Change from baseline to 3 months. ]
    Isometric muscle strength will be assessed using the FysioMeter. Assessed at baseline, 3 and 12 months.

  4. The maximum number of knee-bends in 30s [ Time Frame: Primary endpoint: Change from baseline to 12 months. ]
    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.

  5. The one-leg hop for distance [ Time Frame: Primary endpoint: 12 months. ]
    The one-leg hop for distance is one of three measures of functional performance. Assessed only at 12 months.

  6. The 6 m timed hop [ Time Frame: Primary endpoint: 12 months. ]
    The 6 m timed hop is one of three measures of functional performance. Assessed only at 12 months.

  7. Adverse events [ Time Frame: Primary endpoint: 12 months. ]
    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.


Other Outcome Measures:
  1. EQ-5D [ Time Frame: Primary endpoint: Change from baseline to 12 months. ]
    General health will be assessed using the EQ-5D-5L questionnaire (5-level version), both the descriptive index and the EQ-VAS. This will also allow for a later cost-effectiveness analysis. Assessed at baseline, 3, 6 and 12 months.

  2. Questions on function with Short Message Service (SMS) [ Time Frame: Each week during the first 3 months and after that each month until the 12 months follow-up ]
    The subscale Sport/Rec from the KOOS

  3. Questions on pain with Short Message Service (SMS) [ Time Frame: Each week during the first 3 months and after that each month until the 12 months follow-up ]
    Pain intensity going up/down stairs and pain intensity during sitting/lying on a 11-point Numeric Rating Scale (NRS)

  4. Physical activity level [ Time Frame: Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. ]
  5. Participation in sports (Tegner activity scale) [ Time Frame: Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. ]
  6. Global Perceived Effect (GPE) [ Time Frame: Primary endpoint: 12 months. ]
    Answered on 7-point Likert scale. Assessed at 3, 6 and 12 months.

  7. Patient Acceptable Symptom State (PASS) [ Time Frame: Primary endpoint: 12 months. ]
    "When you think of your knee function, will you consider your current condition as satisfying? By knee function, you should take into account your activities of daily living, sport and recreational activities, your pain and other symptoms and your quality of life". Answered by "yes" or "no". Assessed at 3, 6 and 12 months.

  8. Patient-reported treatment failure. [ Time Frame: Primary endpoint: 12 months. ]
    Only answered by patients answering "no" to PASS. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?". Answered by "yes" or "no".

  9. Patient-reported mechanical symptoms related to the knee [ Time Frame: Assessed at baseline, 3, 6 and 12 months. ]
    Patient-reported mechanical symptoms, i.e. catching and locking of the knee. Presence and frequency answered on 5-point scale.

  10. Knee instability [ Time Frame: Assessed at baseline, 3, 6 and 12 months. ]
    Patient-reported knee instability. Presence and frequency of knee instability answered on a 6-point scale and how much it affects activity level answered on a 6-point scale.

  11. Compliance with exercise (only for patients in the exercise group) [ Time Frame: Assessed at 3 months ]
    The number of exercise sessions that the patient participate in out of the total 24 supervised sessions.

  12. Patient-reported participation in post-surgery exercise (only for patients in the surgery group) [ Time Frame: Assessed at 3 months ]
    Supervised or unsupervised and number of sessions.

  13. Surgery and other treatments during follow-up [ Time Frame: Primary endpoint: 12 months. ]
    Assessed at baseline, 3, 6 and 12 months by self-report and review of medical journals (surgery only).

  14. Pain intensity on a 11-point Numeric Rating Scale (NRS) [ Time Frame: Assessed at 3 months ]
    Before and after each of the 24 supervised exercise sessions the patients will report their pain intensity. Only the patients in the group randomized to exercise and education.

  15. Expanded version of the International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine (ISAKOS) classification of meniscal tears questionnaire [ Time Frame: Day 1 after surgery ]
    Information about location of tear, type of tear and type of treatment (repair or resection) will be collected using an expanded version of the International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine (ISAKOS) classification of meniscal tears questionnaire by the operating surgeon. This will be supplemented with data from surgery reports.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995551


Contacts
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Contact: Søren T Skou, PT, PhD +4523708640 stskou@health.sdu.dk
Contact: Jonas B Thorlund, MSc, PhD +4529125499 jthorlund@health.sdu.dk

Locations
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Denmark
Department of Orthopedic Surgery, Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Søren T Skou    +4523708640    stskou@health.sdu.dk   
Department of Sports Traumatology, Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Søren T Skou       stskou@health.sdu.dk   
Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre Recruiting
Copenhagen, Denmark
Contact: Søren T Skou       stskou@health.sdu.dk   
Department of Orthopedic Surgery, Lillebælt Hospital in Kolding Recruiting
Kolding, Denmark
Contact: Søren T. Skou       stskou@health.sdu.dk   
Department of Orthopedic Surgery, Næstved Hospital Recruiting
Naestved, Denmark
Contact: Søren T Skou       stskou@health.sdu.dk   
Department of Orthopedics and Traumatology, Odense University Hospital Recruiting
Odense, Denmark
Contact: Søren T Skou       stskou@health.sdu.dk   
Elective Surgery Centre, Regionshospitalet Silkeborg Recruiting
Silkeborg, Denmark
Contact: Søren T. Skou       stskou@health.sdu.dk   
Sponsors and Collaborators
University of Southern Denmark
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
Investigators
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Principal Investigator: Søren T. Skou, PT, PhD University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals
Study Chair: Jonas B Thorlund, MSc, PhD University of Southern Denmark
Study Chair: Martin Lind, Prof, MD, PhD, DMSc Aarhus University Hospital
Study Chair: Per Hölmich, Prof, MD, DMSc Copenhagen University Hospital, Amager-Hvidovre
Study Chair: Hans P Jensen, MD Aalborg University Hospital
Study Chair: Carsten Jensen, MSc, PhD Lillebælt Hospital in Kolding
Study Chair: Muhammad Afzal, MD Naestved Hospital
Study Chair: Uffe Jørgensen, Prof, MD, DMSc Odense University Hospital
Study Chair: Mogens Strange Hansen, MD, PhD Elective Surgery Centre, Regionshospitalet Silkeborg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Søren Thorgaard Skou, PT, PhD, associate professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02995551     History of Changes
Other Study ID Numbers: S-20160151
DFF - 6110-00045 ( Other Grant/Funding Number: Danish Council for Independent Research )
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Søren Thorgaard Skou, University of Southern Denmark:
Menisci, Tibial
Knee Injuries
Arthroscopy
Exercise
Young adults
Treatment Outcome
Humans