Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients

NCT01850719 | Completed

• 1 other identifier: NL4418.100.13
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to determine the effectiveness of both arthroscopic knee surgery and physical therapy in the treatment of non-obstructive meniscal injuries in older patients. The investigators assume equal improvement of physical function in both groups and reduced costs with conservative treatment.

Conditions

Meniscal Tear

Keywords

Tibial meniscus; Arthroscopy; Meniscectomy; Conservative treatment; Physical therapy; Osteoarthritis knee joint

Outcome Measures

Primary Outcomes (1)

• International Knee Documentation Committee 'Subjective Knee Form'

  Primary outcome will be change in physical function from baseline to 2 years measured by the International Knee Documentation Committee (IKDC) 'Subjective Knee Form', which has been validated for meniscal injuries. In addition, 1) the investigators will perform an economic analysis alongside the Randomized Controlled Trial (RCT) from a societal perspective and a budget impact analysis from societal, government and insurer perspective. 2\) The primary outcome after 5 years will be investigated

  3, 6, 12, 24 and 60 months

Secondary Outcomes (8)

• RAND-36 Physical Functional Status Scale

  3, 6, 12 and 24 months

• EQ-5D-5L Quality of life measure

  3, 6, 9, 12, 18, 24 and 60 months

• Tegner Activity Scale

  3, 6, 12 and 24 months

• Health Care Utilization and productivity losses

  3, 6, 9, 12, 18 and 24 months

• Patient Specific Complaints questionnaire

  3, 6 ,12 and 24 months

Study Arms (2)

Arthroscopic Partial Meniscectomy

EXPERIMENTAL

Procedure: Arthroscopic Partial Meniscectomy

Physical Therapy

ACTIVE COMPARATOR

Other: Physical Therapy

Interventions

Arthroscopic Partial Meniscectomy PROCEDURE

Arthroscopic partial APM is performed within 4 weeks in day-care. No standard physical therapy is prescribed after surgery, as advised by the Dutch Orthopaedic Association Guidelines.

Also known as: APM

Arthroscopic Partial Meniscectomy

Physical Therapy OTHER

Conservative treatment consist of 16 sessions PT and a home exercise program. These programs are developed for our population, 45-70 years, with a focus on closed-chain strength exercises and cardiovascular exercises. In case conservative treatment has failed, patients can cross-over and delayed APM is then performed. This can be done, from completion of the PT program, during the entire study.

Physical Therapy

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 45 and 70 years of age at presentation.
• A meniscal tear visualized on MRI. The meniscal tear can either be isolated or combined with a partial asymptomatic Anterior Cruciate Ligament (ACL) injury or an asymptomatic degenerative ACL shown on MRI with no abnormal clinical findings (a negative Lachman test and Pivot Shift).
• Mental Competence.
• Willingness to comply with follow up schedule.
• Written informed consent.

You may not qualify if:

• Knee locking or trauma leading to acute surgery.
• One of the following associated injuries on the index knee:
• A symptomatic partial ACL rupture or any total ACL rupture determined by clinical examination (positive Lachman test and/or positive Pivot Shift) and shown on MRI;
• A complete Posterior Cruciate Ligament (PCL) injury;
• Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray;
• An injury to the lateral/posterolateral ligament complex with significantly increased laxity.
• A history of knee surgery other than diagnostic arthroscopy on the index knee.
• Tumors on MRI suspected for a malignancy.
• Obese patients with Body Mass Index (BMI) \> 35.
• ASA 4-5 patients which can severely interfere with rehabilitation.
• General disease that effects physical function or systemic medication/abuse of steroids (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout)
• Any other medical condition or treatment interfering with the completion or assessment of the trial, e.g. contraindications to MRI or surgery.
• Drugs or alcohol abuse.
• Patients unable to speak or read Dutch.

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Stichting Achmea Gezondheidszor: collaborator

Study Sites (10)

Medisch Centrum Alkmaar

Alkmaar, North Holland, Netherlands

Location

St Lucas Andreas Hospital

Amsterdam, North Holland, 1006 AE, Netherlands

Location

Medisch Centrum Jan van Goyen

Amsterdam, North Holland, 1075 HN, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1090 HM, Netherlands

Location

Academic Medical Center University of Amsterdam

Amsterdam, North Holland, 1100 DD, Netherlands

Location

Slotervaart Ziekenhuis

Amsterdam, Netherlands

Location

Tergooi Ziekenhuis

Hilversum, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, Netherlands

Location

Sint Elisabeth Hospital

Tilburg, Netherlands

Location

Diakonessenhuis

Utrecht, 3508 TG, Netherlands

Location

Related Publications (5)

• Noorduyn JCA, van de Graaf VA, Willigenburg NW, Scholten-Peeters GGM, Kret EJ, van Dijk RA, Buchbinder R, Hawker GA, Coppieters MW, Poolman RW; ESCAPE Research Group. Effect of Physical Therapy vs Arthroscopic Partial Meniscectomy in People With Degenerative Meniscal Tears: Five-Year Follow-up of the ESCAPE Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220394. doi: 10.1001/jamanetworkopen.2022.20394.

  PMID: 35802374 DERIVED

• Noorduyn JCA, Glastra van Loon T, van de Graaf VA, Willigenburg NW, Butter IK, Scholten-Peeters GGM, Coppieters MW, Poolman RW; ESCAPE Research Group; Scholtes VAB, Mutsaerts ELAR, Krijnen MR, Moojen DJF, van Deurzen DFP, Bloembergen CH, Wolkenfelt J, de Gast A, Snijders T, Saris DBF, Wolterbeek N, Neeter C, Kerkhoffs GMMJ, Peters RW, van den Brand ICJB, de Vos-Jakobs S, Spoor AB, Gosens T, Rezaie W, Hofstee DJ, Burger BJ, Haverkamp D, Vervest AMJS, van Rheenen TA, Wijsbek AE, van Arkel ERA, Thomassen BJW, Sprague S, van Tulder MW, Schavemaker M, van Dijk R, van der Kraan J. Functional Outcomes of Arthroscopic Partial Meniscectomy Versus Physical Therapy for Degenerative Meniscal Tears Using a Patient-Specific Score: A Randomized Controlled Trial. Orthop J Sports Med. 2020 Oct 29;8(10):2325967120954392. doi: 10.1177/2325967120954392. eCollection 2020 Oct.

  PMID: 33195707 DERIVED

• van de Graaf VA, van Dongen JM, Willigenburg NW, Noorduyn JCA, Butter IK, de Gast A, Saris DBF, van Tulder MW, Poolman RW; ESCAPE Research Group. How do the costs of physical therapy and arthroscopic partial meniscectomy compare? A trial-based economic evaluation of two treatments in patients with meniscal tears alongside the ESCAPE study. Br J Sports Med. 2020 May;54(9):538-545. doi: 10.1136/bjsports-2018-100065. Epub 2019 Jun 21.

  PMID: 31227493 DERIVED

• van de Graaf VA, Noorduyn JCA, Willigenburg NW, Butter IK, de Gast A, Mol BW, Saris DBF, Twisk JWR, Poolman RW; ESCAPE Research Group. Effect of Early Surgery vs Physical Therapy on Knee Function Among Patients With Nonobstructive Meniscal Tears: The ESCAPE Randomized Clinical Trial. JAMA. 2018 Oct 2;320(13):1328-1337. doi: 10.1001/jama.2018.13308.

  PMID: 30285177 DERIVED

• van de Graaf VA, Scholtes VA, Wolterbeek N, Noorduyn JC, Neeter C, van Tulder MW, Saris DB, de Gast A, Poolman RW; Escape Research Group. Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45 years with non-obstructive meniscal tears (ESCAPE study): protocol of a randomised controlled trial. BMJ Open. 2016 Dec 21;6(12):e014381. doi: 10.1136/bmjopen-2016-014381.

  PMID: 28003302 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Rudolf W Poolman, MD PhD

  Dept. Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis

  PRINCIPAL INVESTIGATOR

• Arthur de Gast, MD PhD

  Dept. Orthopaedic Surgery Diakonessenhuis, Utrecht

  PRINCIPAL INVESTIGATOR

• Thijs ThM van der SChoot, MD PhD

  Dean Board of Directors Onze Lieve Vrouwe Gasthuis

  STUDY CHAIR

• Eduard LA Mutsaerts, MD PhD

  Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis

  PRINCIPAL INVESTIGATOR

• Victor A van de Graaf, MD

  Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis

  STUDY CHAIR

• Gino MM Kerkhoffs, MD PhD

  Dept. of Orthopaedic Surgery Academic Medical Center University of Amsterdam

  PRINCIPAL INVESTIGATOR

• Julius Wolkenfelt, MD

  Dept. of Orthopaedic Surgery St. Lucas Andreas Hospital

  PRINCIPAL INVESTIGATOR

• Maurits W van Tulder, professor

  Professor of Health Technology Assessment Dept. Health Sciences VU University Amsterdam

  STUDY DIRECTOR

• Vanessa AB Scholtes, PhD

  Research coordinator Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis

  STUDY DIRECTOR

• Nienke Wolterbeek, PhD

  Research coordinator Dept. of Orthopaedic Surgery St. Antonius Hospital

  STUDY DIRECTOR

• Camille Neeter, PhD

  Neeter Physiotherapy Amsterdam

  STUDY DIRECTOR

• Ewoud RA van Arkel, MD PhD

  Dept. of Orthopaedic Surgery MC Haaglanden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 9, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

NL (10)