Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults

NCT02995551 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2022-02-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER
  • Copenhagen University Hospital, Hvidovre

    collaborator OTHER
  • Aalborg University Hospital

    collaborator OTHER
  • Sygehus Lillebaelt

    collaborator OTHER
  • Naestved Hospital

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • Slagelse Hospital

    collaborator OTHER
  • Danish Council for Independent Research

    collaborator OTHER
  • IMK Almene Fond

    collaborator OTHER
  • Lundbeck Foundation

    collaborator OTHER
  • The Danish Rheumatism Association

    collaborator OTHER
  • Spar Nord Foundation

    collaborator UNKNOWN
  • Association of Danish Physiotherapists

    collaborator OTHER
  • Regionshospitalet Silkeborg

    collaborator OTHER
  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Søren T. Skou, PT, PhD · University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals

  • Jonas B Thorlund, MSc, PhD · University of Southern Denmark

  • Martin Lind, Prof, MD, PhD, DMSc · Aarhus University Hospital

  • Per Hölmich, Prof, MD, DMSc · Copenhagen University Hospital, Amager-Hvidovre

  • Hans P Jensen, MD · Aalborg University Hospital

  • Carsten Jensen, MSc, PhD · Lillebælt Hospital in Kolding

  • Muhammad Afzal, MD · Naestved Hospital

  • Uffe Jørgensen, Prof, MD, DMSc · Odense University Hospital

  • Mogens Strange Hansen, MD, PhD · Elective Surgery Centre, Regionshospitalet Silkeborg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2021-02-28
Completion
2022-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02995551 on ClinicalTrials.gov