Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults

NCT02995551 | Completed

• 2 other identifiers: S-20160151DFF - 6110-00045
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 7

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.

Conditions

Tear of Meniscus of Knee

Keywords

Menisci, Tibial; Knee Injuries; Arthroscopy; Exercise; Young adults; Treatment Outcome; Humans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The five KOOS subscales

  Primary endpoint: Change from baseline to 12 months.

• Western Ontario Meniscal Evaluation Tool (WOMET)

  Primary endpoint: Change from baseline to 12 months.

• Isometric muscle strength

  Primary endpoint: Change from baseline to 3 months.

• The maximum number of knee-bends in 30s

  Primary endpoint: Change from baseline to 12 months.

• The one-leg hop for distance

  Primary endpoint: 12 months.

Other Outcomes (15)

• EQ-5D

  Primary endpoint: Change from baseline to 12 months.

• Questions on function with Short Message Service (SMS)

  Each week during the first 3 months and after that each month until the 12 months follow-up

• Questions on pain with Short Message Service (SMS)

  Each week during the first 3 months and after that each month until the 12 months follow-up

Study Arms (2)

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).

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.

Behavioral: Exercise and education

Interventions

Arthroscopic meniscal repair or resection PROCEDURE

Arthroscopic meniscal repair or resection following standard procedures.

Arthroscopy

Exercise and education BEHAVIORAL

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.

Exercise and Education

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (7)

Department of Orthopedic Surgery, Aalborg University Hospital

Aalborg, Denmark

Location

Department of Sports Traumatology, Aarhus University Hospital

Aarhus, Denmark

Location

Department of Orthopedic Surgery, Copenhagen University Hospital, Amager-Hvidovre

Copenhagen, Denmark

Location

Department of Orthopedic Surgery, Lillebælt Hospital in Kolding

Kolding, Denmark

Location

Department of Orthopedic Surgery, Næstved Hospital

Næstved, Denmark

Location

Department of Orthopedics and Traumatology, Odense University Hospital

Odense, Denmark

Location

Elective Surgery Centre, Regionshospitalet Silkeborg

Silkeborg, Denmark

Location

Related Publications (4)

• 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.

  PMID: 38319181 DERIVED

• 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.

  PMID: 37879858 DERIVED

• 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.

  PMID: 36878666 DERIVED

• 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.

  PMID: 28827270 DERIVED

MeSH Terms

Conditions

Knee Injuries; Motor Activity

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Søren T. Skou, PT, PhD

  University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, Professor

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 16, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2022
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (7)