Meniscus LesionNCT03462134
Predicting the Outcome After Treatment of Meniscal Tears
An observational study of Meniscus Lesion and Surveys and Questionnaires, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
Trial summary
In this study the investigators examined the ability of orthopaedic surgeons to predict the outcome of surgery and non-operative treatment in patients (age 45 to 70) with a non-obstructive meniscal tear. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Meniscus Lesion, Surveys and Questionnaires
- What is being tested?
- Survey
- How many people
- 194 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2018to 1 Jan 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: 1. Orthopaedic surgeons and residents registered at the Dutch Orthopaedic Associations. 2. A sample of orthopaedic surgeons from Australia
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1090 HM
About this study
Official title: Can Orthopaedic Surgeons Predict the Outcome of Treatment in Patients With Meniscal Tears? The Results of an International Survey.
In this study the investigators examined the ability of orthopaedic surgeons to predict the outcome of surgery and non-operative treatment in patients (age 45 to 70) with a non-obstructive meniscal tear.
Read the detailed description
The additional benefits of Arthroscopic Partial Meniscectomy (APM) in middle aged patients with a non-obstructive meniscal tear are under scrutiny for years. Despite the most recent publications recommending to apply non-operative treatment (exercise therapy, injections, drugs) instead of APM in this patient group, the expected decrease in number of operations is slower then expected. Orthopaedic surgeons therefore seem unconvinced by the evidence to change practice.
For this reason the investigators conducted an international survey amongst orthopaedic surgeons in which the investigators aimed to (1) determine the ability of orthopaedic surgeons to predict the outcomes of APM and physical therapy (PT) in middle aged patients with a non-obstructive meniscal tear, and (2) to determine which patient factors direct surgeons towards APM and towards PT.
- Conditions
- Meniscus Lesion, Surveys and Questionnaires
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey amongst orthopaedic surgeons
| Study group | Role | What they receive |
|---|---|---|
| Survey amongst orthopaedic surgeons | Selected of 20 patients from the Escape trial (NCT01850719) Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of orthopaedics surgeons to predict the outcome of treatment
In this survey, participants are provided with 20 cases and asked for their treatment of choice (APM or physical therapy). Subsequently, participants are asked for the expected outcome, which is change in knee function on the International Knee Documentation Committee 'Subjective Knee Form' (IKDC).
These data are used to assess to what extend orthopaedic surgeons are capable of predicting the outcome of surgical and non-operative treatment of meniscal tears in a random sample of patients from the Escape trial.
Measured: 2 years
Secondary outcomes (1)
To assess which patient specific factors are found important by orthopaedic surgeons in choosing their treatment of first choice
In this survey, participants are asked to choose from a list of patient specific factors, which of these direct their treatment choice toward APM, and which towards non-operative treatment.
These data are used to examine which patient specific factors are directing orthopaedic surgeons towards APM and towards PT. These factors will help future research focusing in creating patient specific profiles.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Jan 2018
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meniscus LesionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- University of New South Wales, Mayo Clinic
- Responsible party
- Principal investigator, Victor van de Graaf, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462134
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2021
- First submitted
- 2 Mar 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van de Graaf VA, Bloembergen CH MD, Willigenburg NW PhD, Noorduyn JCA MSc, Saris DB, Harris IA, Poolman RW; ESCAPE Research Group. Can even experienced orthopaedic surgeons predict who will benefit from surgery when patients present with degenerative meniscal tears? A survey of 194 orthopaedic surgeons who made 3880 predictions. Br J Sports Med. 2020 Mar;54(6):354-359. doi: 10.1136/bjsports-2019-100567. Epub 2019 Aug 1.
PubMed 31371339
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Orthopaedic Surgeons Predict the Outcome of Treatment in Patients With Meniscal Tears? The Results of an International Survey.
- ClinicalTrials.gov ID
- NCT03462134
- Acronym / sponsor ID
- 1
- Conditions
- Meniscus Lesion, Surveys and Questionnaires
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Collaborators
- University of New South Wales, Mayo Clinic
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 12 Mar 2018 (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.
In this study the investigators examined the ability of orthopaedic surgeons to predict the outcome of surgery and non-operative treatment in patients (age 45 to 70) with a non-obstructive meniscal tear.
Detailed description
The additional benefits of Arthroscopic Partial Meniscectomy (APM) in middle aged patients with a non-obstructive meniscal tear are under scrutiny for years. Despite the most recent publications recommending to apply non-operative treatment (exercise therapy, injections, drugs) instead of APM in this patient group, the expected decrease in number of operations is slower then expected. Orthopaedic surgeons therefore seem unconvinced by the evidence to change practice.
For this reason the investigators conducted an international survey amongst orthopaedic surgeons in which the investigators aimed to (1) determine the ability of orthopaedic surgeons to predict the outcomes of APM and physical therapy (PT) in middle aged patients with a non-obstructive meniscal tear, and (2) to determine which patient factors direct surgeons towards APM and towards PT.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey amongst orthopaedic surgeons | – | Other: SurveySelected of 20 patients from the Escape trial (NCT01850719) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Orthopaedic surgeons and residents registered at the Dutch Orthopaedic Associations. 2. A sample of orthopaedic surgeons from Australia
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
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 |
|---|---|---|
| SurveySurvey amongst orthopaedic surgeons | Other | Survey amongst orthopaedic surgeons |
Primary outcome
The ability of orthopaedics surgeons to predict the outcome of treatment
Time frame: 2 years
In this survey, participants are provided with 20 cases and asked for their treatment of choice (APM or physical therapy). Subsequently, participants are asked for the expected outcome, which is change in knee function on the International Knee Documentation Committee 'Subjective Knee Form' (IKDC). These data are used to assess to what extend orthopaedic surgeons are capable of predicting the outcome of surgical and non-operative treatment of meniscal tears in a random sample of patients from the Escape trial.
1 secondary outcome
To assess which patient specific factors are found important by orthopaedic surgeons in choosing their treatment of first choice
Time frame: 2 years
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 24 Feb 2021.
- Derived from this study: PubMed 31371339van de Graaf VA, Bloembergen CH MD, Willigenburg NW PhD, Noorduyn JCA MSc, Saris DB, Harris IA, Poolman RW; ESCAPE Research Group. Can even experienced orthopaedic surgeons predict who will benefit from surgery when patients present with degenerative meniscal tears? A survey of 194 orthopaedic surgeons who made 3880 predictions. Br J Sports Med. 2020 Mar;54(6):354-359. doi: 10.1136/bjsports-2019-100567. Epub 2019 Aug 1.
- Individual participant dataSharing planned: Undecided
Related trials for Meniscus Lesion
Recruiting
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Meniscus Lesion
Recruiting
Kinesiotaping in Isolated Meniscus Injuries
Meniscus Injury, Kinesio Taping
Not yet recruitingObservational study
Long-term Follow-up of Actifit® Meniscal Scaffold Patients.
Meniscus Lesion, Meniscus Tear
RecruitingObservational study
Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy
Meniscus Rupture, Meniscus Injury
Recruiting
Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis
Platelets-rich Plasma, Osteoarthritis Knees Both
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Lesion and Surveys and Questionnaires, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
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 5 inclusion and 13 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The ability of orthopaedics surgeons to predict the outcome of treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03462134, which also lists 1 linked publication.
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 24 Feb 2021.