Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients

NCT ID: NCT01850719

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-10-31

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.

Detailed Description

Rationale: Arthroscopic Partial Meniscectomy (APM) is the most performed orthopaedic procedure and is current standard treatment for patients with meniscal tears. Since superiority of APM over conservative treatment has not well been described and studies with direct comparison between APM and conservative treatment are sparse, therefore there is risk of large healthcare inefficiency.

Study design: Non-inferiority multicenter randomized controlled trial with an economic evaluation alongside. The study will be conducted by the Orthopaedic Research Consortium Mid-West Netherlands and performed in 6 clinics, including 2 academic medical centers.

402 patients between 45 and 70 years with Magnetic Resonance Imaging (MRI)-confirmed symptomatic, non-obstructive meniscal tears will be included. Patients will be assigned to either APM (n=201) or Physical Therapy (PT; n=201), with optional delayed APM (cross-over) when conservative treatment has failed. Block randomization will be done stratified for age and site. Data will be analysed on both intention to treat and per protocol basis.

Measurement points:

• Patients will be asked to complete questionnaires at baseline and 3, 6, 9, 12, 18, 24 and 60 months.
• At both 3 and 24 months they will visit the outpatient department for physical examination.
• At 24 and 60 months an X-ray will be obtained.

Sample size calculation: 402 patients, based on a power of 90%, an alpha of 0.05, a standard deviation of 20 points and a non-inferiority threshold of 8 points on the IKDC 'Subjective Knee Form'. Loss to follow up and cross-over have been taken into account in this calculation.

Conditions

Meniscal Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arthroscopic Partial Meniscectomy

Group Type: EXPERIMENTAL

Arthroscopic Partial Meniscectomy

Intervention Type: 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.

Physical Therapy

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: 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.

Interventions

Arthroscopic Partial Meniscectomy

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.

Intervention Type: PROCEDURE

Physical Therapy

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.

Intervention Type: OTHER

Other Intervention Names

APM

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Knee locking or trauma leading to acute surgery.
• One of the following associated injuries on the index knee:

1. 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;

2. A complete Posterior Cruciate Ligament (PCL) injury;

3. Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray;

4. 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Stichting Achmea Gezondheidszor

OTHER

Sponsor Role: collaborator

Onze Lieve Vrouwe Gasthuis

OTHER

Sponsor Role: lead

Responsible Party

Victor van de Graaf

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rudolf W Poolman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis

Arthur de Gast, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. Orthopaedic Surgery Diakonessenhuis, Utrecht

Thijs ThM van der SChoot, MD PhD

Role: STUDY_CHAIR

Dean Board of Directors Onze Lieve Vrouwe Gasthuis

Eduard LA Mutsaerts, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis

Victor A van de Graaf, MD

Role: STUDY_CHAIR

Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis

Gino MM Kerkhoffs, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Orthopaedic Surgery Academic Medical Center University of Amsterdam

Julius Wolkenfelt, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Orthopaedic Surgery St. Lucas Andreas Hospital

Maurits W van Tulder, professor

Role: STUDY_DIRECTOR

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

Vanessa AB Scholtes, PhD

Role: STUDY_DIRECTOR

Research coordinator Dept. of Orthopaedic Surgery Onze Lieve Vrouwe Gasthuis

Nienke Wolterbeek, PhD

Role: STUDY_DIRECTOR

Research coordinator Dept. of Orthopaedic Surgery St. Antonius Hospital

Camille Neeter, PhD

Role: STUDY_DIRECTOR

Neeter Physiotherapy Amsterdam

Ewoud RA van Arkel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Orthopaedic Surgery MC Haaglanden

Locations

Medisch Centrum Alkmaar

Alkmaar, North Holland, Netherlands

St Lucas Andreas Hospital

Amsterdam, North Holland, Netherlands

Medisch Centrum Jan van Goyen

Amsterdam, North Holland, Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Academic Medical Center University of Amsterdam

Amsterdam, North Holland, Netherlands

Slotervaart Ziekenhuis

Amsterdam, , Netherlands

Tergooi Ziekenhuis

Hilversum, , Netherlands

Medisch Centrum Haaglanden

The Hague, , Netherlands

Sint Elisabeth Hospital

Tilburg, , Netherlands

Diakonessenhuis

Utrecht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 35802374 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33195707 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31227493 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30285177 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28003302 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NL4418.100.13

Identifier Type: -

Identifier Source: org_study_id