Clinical trial NCT02995551: Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tear of Meniscus of Knee
Keywords: Menisci, Tibial
Knee Injuries
Arthroscopy
Exercise
Young adults
Treatment Outcome
Humans
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Copenhagen University Hospital, Hvidovre
name: Aalborg University Hospital
name: Sygehus Lillebaelt
name: Naestved Hospital
name: Odense University Hospital
name: Slagelse Hospital
name: Danish Council for Independent Research
name: IMK Almene Fond
name: Lundbeck Foundation
name: The Danish Rheumatism Association
name: Spar Nord Foundation
name: Association of Danish Physiotherapists
name: Regionshospitalet Silkeborg
First posted: 2016-12-16
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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):

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.

Eligibility 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.)

Primary outcomes:
measure: the Knee Injury and Osteoarthritis Outcome Score (KOOS4)
timeFrame: Primary endpoint: Change from baseline to 12 months.
Secondary outcomes:
measure: The five KOOS subscales
timeFrame: Primary endpoint: Change from baseline to 12 months.
measure: Western Ontario Meniscal Evaluation Tool (WOMET)
timeFrame: Primary endpoint: Change from baseline to 12 months.
measure: Isometric muscle strength
timeFrame: Primary endpoint: Change from baseline to 3 months.
measure: The maximum number of knee-bends in 30s
timeFrame: Primary endpoint: Change from baseline to 12 months.
measure: The one-leg hop for distance
timeFrame: Primary endpoint: 12 months.
measure: The 6 m timed hop
timeFrame: Primary endpoint: 12 months.
measure: Adverse events
timeFrame: Primary endpoint: 12 months.
measure: Structural knee joint changes
timeFrame: Baseline to 24 months
Other outcomes:
measure: EQ-5D
timeFrame: Primary endpoint: Change from baseline to 12 months.
measure: Questions on function with Short Message Service (SMS)
timeFrame: Each week during the first 3 months and after that each month until the 12 months follow-up
measure: Questions on pain with Short Message Service (SMS)
timeFrame: Each week during the first 3 months and after that each month until the 12 months follow-up
measure: Physical activity level
timeFrame: Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
measure: Participation in sports (Tegner activity scale)
timeFrame: Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
measure: Global Perceived Effect (GPE)
timeFrame: Primary endpoint: 12 months.
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Primary endpoint: 12 months.
measure: Patient-reported treatment failure.
timeFrame: Primary endpoint: 12 months. Will also be assessed after 24 months.
measure: Patient-reported mechanical symptoms related to the knee
timeFrame: Assessed at baseline, 3, 6 and 12 months.
measure: Knee instability
timeFrame: Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
measure: Compliance with exercise (only for patients in the exercise group)
timeFrame: Assessed at 3 months
measure: Patient-reported participation in post-surgery exercise (only for patients in the surgery group)
timeFrame: Assessed at 3 months
measure: Surgery and other treatments during follow-up
timeFrame: Primary endpoint: 12 months.
measure: Pain intensity on a 11-point Numeric Rating Scale (NRS)
timeFrame: Assessed at 3 months
measure: Expanded version of the International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine (ISAKOS) classification of meniscal tears questionnaire
timeFrame: Day 1 after surgery
Locations:
city: Aalborg
country: Denmark
facility: Department of Orthopedic Surgery, Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Department of Sports Traumatology, Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre
city: Kolding
country: Denmark
facility: Department of Orthopedic Surgery, Lillebælt Hospital in Kolding
city: Naestved
country: Denmark
facility: Department of Orthopedic Surgery, Næstved Hospital
city: Odense
country: Denmark
facility: Department of Orthopedics and Traumatology, Odense University Hospital
city: Silkeborg
country: Denmark
facility: Elective Surgery Centre, Regionshospitalet Silkeborg
Study officials:
affiliation: University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals
name: Søren T. Skou, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Jonas B Thorlund, MSc, PhD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Martin Lind, Prof, MD, PhD, DMSc
role: STUDY_CHAIR
affiliation: Copenhagen University Hospital, Amager-Hvidovre
name: Per Hölmich, Prof, MD, DMSc
role: STUDY_CHAIR
affiliation: Aalborg University Hospital
name: Hans P Jensen, MD
role: STUDY_CHAIR
affiliation: Lillebælt Hospital in Kolding
name: Carsten Jensen, MSc, PhD
role: STUDY_CHAIR
affiliation: Naestved Hospital
name: Muhammad Afzal, MD
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Uffe Jørgensen, Prof, MD, DMSc
role: STUDY_CHAIR
affiliation: Elective Surgery Centre, Regionshospitalet Silkeborg
name: Mogens Strange Hansen, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.