Meniscus Tear, TibialNCT05068843
Arthroscopic Partial Meniscectomy Versus Exercise Therapy for Meniscal Injuries in Older Patients, a 5 Year Follow up.
A study testing arthroscopic partial meniscectomy and Physical therapy in people with Meniscus Tear, Tibial and Osteoarthritis, Knee, run by Onze Lieve Vrouwe Gasthuis.
Trial summary
Arthroscopic partial meniscectomie (APM) offers little short-term to medium-term benefit above sham surgery or non-surgical management for knee function in most patients with a symptomatic degenerative meniscus tear. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Meniscus Tear, Tibial, Osteoarthritis, Knee
- What is being tested?
- arthroscopic partial meniscectomy and Physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- No sites listed yet
- Study dates
- 13 Jul 2013to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 to 70 years old MRI confirmed, non-obstructive and symptomatic meniscal tear
Who cannot join
- Knee locking or trauma leading to acute surgery;
- ▸ Associated injuries on the index knee consisting of:
- Symptomatic partial or total tear of the anterior cruciate ligament (ACL),
- Posterior cruciate ligament tear,
- OA of the knee, grade 4 on the Kellgren and Lawrence Grading Scale,
- An injury to the lateral or posterolateral ligament complex with significant laxity;
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- Previous knee surgery on the index knee (with the exception of diagnostic arthroscopy);
- Tumour that is suspected of malignancy, detectable on MRI;
- Obesity with a body mass index >35;
- American Society of Anesthesiologists (ASA) class 4 or 5 patients;
- General disease that effects physical function or systemic medication/abuse of steroids;
- Any other medical condition or treatment interfering with the completion or assessment of the trial, for example, contraindications to MRI or surgery;
- Drugs or alcohol abuse;
- Patients unable to fill out the Dutch questionnaires.
About this study
Official title: Arthroscopic Partial Meniscectomy Versus Physical Therapy for Patients Over 45 Years With a Meniscal Tears: 5-year Follow-up of the ESCAPE Trial
Arthroscopic partial meniscectomie (APM) offers little short-term to medium-term benefit above sham surgery or non-surgical management for knee function in most patients with a symptomatic degenerative meniscus tear. It is suggested that APM is associated with increased risk of accelerated progression of knee osteoarthritis in middle-aged to older patients.
With the 5 year follow-up of the ESCAPE trial we will investigate the longterm results of APM and physical therapy in patients with a meniscal tear over 45 years old.
- Conditions
- Meniscus Tear, Tibial, Osteoarthritis, Knee
- Being tested
- arthroscopic partial meniscectomy, Physical therapy
- Medical subject headings
- Tibial Meniscus Injuries, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic partial meniscectomyProcedure or surgery
Also called meniscal surgery, APM
In the surgery group, the orthopaedic surgeon performed an arthroscopic partial meniscectomy within 4 weeks after allocation. The surgeon removed the damaged part of the meniscus, until a stable and solid meniscus remained. All patients received written post-operative instructions. Eight weeks after surgery, patients received a consult in the outpatient orthopaedic clinic. In agreement with the Dutch Orthopaedic Association Guidelines, patients were referred to physical therapy when signs of abnormal recovery were present.
Physical therapyOther
Also called exercise therapy
The treatment protocol consisted of a physical therapist-led incremental exercise program over a period of eight weeks, containing 16 sessions of 30 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic partial meniscectomy | Active comparator | In the surgery group, the orthopaedic surgeon performed an arthroscopic partial meniscectomy (APM) within 4 weeks after allocation. The surgeon removed the damaged part of the meniscus, until a stable and solid meniscus remained. All patients received written post-operative instructions. Eight weeks after surgery, patients received a consult in the outpatient orthopaedic clinic. In agreement with the Dutch Orthopaedic Association Guidelines, patients were referred to physical therapy when signs of abnormal recovery were present.
Other Names:
APM meniscal surgery surgery Receives: Procedure: arthroscopic partial meniscectomy |
| Physical therapy | Other | The physical therapy program consisted of a physical therapist-led incremental exercise program containing of coordination/balance, closed kinetic chain strengths and cardiovascular exercises (see Appendix 1). The program was designed for 8 weeks with a total of 16 treatment sessions, each with a duration of 30 minutes. All 16 sessions were reimbursed. If knee symptoms persisted following the physical therapy program (e.g., knee pain, limitations in daily activities or mechanical dysfunction ), the patient could attend additional physical therapy sessions (not reimbursed by the study) or have meniscal surgery, depending on a shared decision after consultation with their orthopaedic surgeon. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire to assess patient reported knee functionWe assessed knee OA on radiographs and patient reported frequency of knee pain during activities was assessed as part of the IKDC questionnaire.
Measured: 60 months
Secondary outcomes (4)
Radiographic Knee osteoarthritis
The OARSI atlas is a semi-quantitative instrument with focus to assess the severity of joint space narrowing and osteophytes in knee OA. We considered radiographic knee OA if any of the follow three criteria were met: 1) Joint space narrowing of grade 2 or higher; 2) sum of osteophyte grades ≥2 or 3) grade 1 joint space narrowing in combination with a grade 1 osteophyte.
Measured: 60 months
Symptomatic knee osteoarthritis (OA)
Our main outcome is symptomatic knee osteoarthritis (OA). Symptomatic knee OA is a combination of knee OA assessed on radiograph and patient reported frequency of knee pain.
We assessed knee OA on radiographs and patient reported frequency of knee pain during activities was assessed as part of the IKDC questionnaire.
Measured: 60 months
Patient reported knee pain during weight bearing
Patient reported knee pain during weight bearing assessed on visual analogue scale from 0-100
Measured: 60 months
Patient reported quality of life
Quality of life assessed by the Euroqol 5 diminesions 5 Levels
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start13 Jul 2013
- Primary completion1 Nov 2020
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus Tear, TibialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudolf W Poolman, MD PhD, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068843
- Sponsor's protocol ID
- 3
- Status last verified
- Nov 2023
- First submitted
- 23 Feb 2021
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: available on request
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Partial Meniscectomy Versus Physical Therapy for Patients Over 45 Years With a Meniscal Tears: 5-year Follow-up of the ESCAPE Trial
- ClinicalTrials.gov ID
- NCT05068843
- Acronym / sponsor ID
- 3
- Conditions
- Meniscus Tear, Tibial, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Study start
- 13 Jul 2013 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arthroscopic partial meniscectomie (APM) offers little short-term to medium-term benefit above sham surgery or non-surgical management for knee function in most patients with a symptomatic degenerative meniscus tear. It is suggested that APM is associated with increased risk of accelerated progression of knee osteoarthritis in middle-aged to older patients.
With the 5 year follow-up of the ESCAPE trial we will investigate the longterm results of APM and physical therapy in patients with a meniscal tear over 45 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic partial meniscectomy | Active comparator | Procedure: arthroscopic partial meniscectomyIn the surgery group, the orthopaedic surgeon performed an arthroscopic partial meniscectomy (APM) within 4 weeks after allocation. The surgeon removed the damaged part of the meniscus, until a stable and solid meniscus remained. All patients received written post-operative instructions. Eight weeks after surgery, patients received a consult in the outpatient orthopaedic clinic. In agreement with the Dutch Orthopaedic Association Guidelines, patients were referred to physical therapy when signs of abnormal recovery were present. Other Names: APM meniscal surgery surgery |
| Physical therapy | Other | Other: Physical therapyThe physical therapy program consisted of a physical therapist-led incremental exercise program containing of coordination/balance, closed kinetic chain strengths and cardiovascular exercises (see Appendix 1). The program was designed for 8 weeks with a total of 16 treatment sessions, each with a duration of 30 minutes. All 16 sessions were reimbursed. If knee symptoms persisted following the physical therapy program (e.g., knee pain, limitations in daily activities or mechanical dysfunction ), the patient could attend additional physical therapy sessions (not reimbursed by the study) or have meniscal surgery, depending on a shared decision after consultation with their orthopaedic surgeon. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 45 to 70 years old MRI confirmed, non-obstructive and symptomatic meniscal tear
Key exclusion criteria (14 listed)
- Knee locking or trauma leading to acute surgery;
- Symptomatic partial or total tear of the anterior cruciate ligament (ACL),
- Posterior cruciate ligament tear,
- OA of the knee, grade 4 on the Kellgren and Lawrence Grading Scale,
- An injury to the lateral or posterolateral ligament complex with significant laxity;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic partial meniscectomyAlso: meniscal surgery, APMIn the surgery group, the orthopaedic surgeon performed an arthroscopic partial meniscectomy within 4 weeks after allocation. The surgeon removed the damaged part of the meniscus, until a stable and solid meniscus remained. All patients received written post-operative instructions. Eight weeks after surgery, patients received a consult in the outpatient orthopaedic clinic. In agreement with the Dutch Orthopaedic Association Guidelines, patients were referred to physical therapy when signs of abnormal recovery were present. | Procedure or surgery | Arthroscopic partial meniscectomy |
| Physical therapyAlso: exercise therapyThe treatment protocol consisted of a physical therapist-led incremental exercise program over a period of eight weeks, containing 16 sessions of 30 minutes each. | Other | Physical therapy |
Primary outcome
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire
Time frame: 60 months
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire to assess patient reported knee functionWe assessed knee OA on radiographs and patient reported frequency of knee pain during activities was assessed as part of the IKDC questionnaire.
4 secondary outcomes
Radiographic Knee osteoarthritis
Time frame: 60 months
Symptomatic knee osteoarthritis (OA)
Time frame: 60 months
Patient reported knee pain during weight bearing
Time frame: 60 months
Patient reported quality of life
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: Yes. available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic partial meniscectomy and Physical therapy in people with Meniscus Tear, Tibial and Osteoarthritis, Knee, run by Onze Lieve Vrouwe Gasthuis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Documentation Committee Subjective Knee Form (IKDC) questionnaire (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.