Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults

Tear of Meniscus of Knee Clinical Trial

— DREAM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995551
• Other study ID #: S-20160151
• Secondary ID: DFF - 6110-00045
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: February 2022

Study information

• Verified date: January 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2022
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Tear of Meniscus of Knee

Intervention

Procedure:
• Arthroscopic meniscal repair or resection
Arthroscopic meniscal repair or resection following standard procedures.

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.

Locations

Country	Name	City	State
Denmark	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	Naestved
Denmark	Department of Orthopedics and Traumatology, Odense University Hospital	Odense
Denmark	Elective Surgery Centre, Regionshospitalet Silkeborg	Silkeborg

Sponsors (15)

Lead Sponsor	Collaborator
University of Southern Denmark	Aalborg University Hospital, Aarhus University Hospital, Association of Danish Physiotherapists, Copenhagen University Hospital, Hvidovre, Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, Naestved Hospital, Odense University Hospital, Regionshospitalet Silkeborg, Slagelse Hospital, Spar Nord Foundation, Sygehus Lillebaelt, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EQ-5D	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. Will also be assessed after 24 months.	Primary endpoint: Change from baseline to 12 months.
Other	Questions on function with Short Message Service (SMS)	The subscale Sport/Rec from the KOOS	Each week during the first 3 months and after that each month until the 12 months follow-up
Other	Questions on pain with Short Message Service (SMS)	Pain intensity going up/down stairs and pain intensity during sitting/lying on a 11-point Numeric Rating Scale (NRS)	Each week during the first 3 months and after that each month until the 12 months follow-up
Other	Physical activity level		Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
Other	Participation in sports (Tegner activity scale)		Primary endpoint: 12 months. Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
Other	Global Perceived Effect (GPE)	Answered on 7-point Likert scale. Assessed at 3, 6 and 12 months. Will also be assessed after 24 months.	Primary endpoint: 12 months.
Other	Patient Acceptable Symptom State (PASS)	"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. Will also be assessed after 24 months.	Primary endpoint: 12 months.
Other	Patient-reported treatment failure.	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".	Primary endpoint: 12 months. Will also be assessed after 24 months.
Other	Patient-reported mechanical symptoms related to the knee	Patient-reported mechanical symptoms, i.e. catching and locking of the knee. Presence and frequency answered on 5-point scale.	Assessed at baseline, 3, 6 and 12 months.
Other	Knee instability	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.	Assessed at baseline, 3, 6 and 12 months. Will also be assessed after 24 months.
Other	Compliance with exercise (only for patients in the exercise group)	The number of exercise sessions that the patient participate in out of the total 24 supervised sessions.	Assessed at 3 months
Other	Patient-reported participation in post-surgery exercise (only for patients in the surgery group)	Supervised or unsupervised and number of sessions.	Assessed at 3 months
Other	Surgery and other treatments during follow-up	Assessed at baseline, 3, 6 and 12 months by self-report and review of medical journals (surgery only). Other knee surgery will also be assessed at 24 months.	Primary endpoint: 12 months.
Other	Pain intensity on a 11-point Numeric Rating Scale (NRS)	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.	Assessed at 3 months
Other	Expanded version of the International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine (ISAKOS) classification of meniscal tears questionnaire	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.	Day 1 after surgery
Primary	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.	Primary endpoint: Change from baseline to 12 months.
Secondary	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.	Primary endpoint: Change from baseline to 12 months.
Secondary	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.	Primary endpoint: Change from baseline to 12 months.
Secondary	Isometric muscle strength	Isometric muscle strength will be assessed using the FysioMeter. Assessed at baseline, 3 and 12 months.	Primary endpoint: Change from baseline to 3 months.
Secondary	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.	Primary endpoint: Change from baseline to 12 months.
Secondary	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.	Primary endpoint: 12 months.
Secondary	The 6 m timed hop	The 6 m timed hop is one of three measures of functional performance. Assessed only at 12 months.	Primary endpoint: 12 months.
Secondary	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.	Primary endpoint: 12 months.
Secondary	Structural knee joint changes	Structural knee joint changes from baseline to 24 months will be assessed using the Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS).	Baseline to 24 months