MeniscectomyAIRNCT03696836
AIR (Artificial Implant for Medial Meniscus Replacement) Study
A study testing Trammpolin® meniscus prosthesis in people with Meniscectomy and Osteo Arthritis Knee, run by ATRO Medical B.V. at 3 sites in Netherlands.
Trial summary
The AIR Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® meniscus prosthesis system. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Meniscectomy, Osteo Arthritis Knee
- What is being tested?
- Trammpolin® meniscus prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesNetherlands
- Study dates
- 11 Oct 2018to 1 Jul 2021
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has medial compartment joint pain with > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
- Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score)
- Is between age 30 and 65 years (inclusive) at the time of screening
- Has neutral alignment ± 5° of the mechanical axis, i.e., the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine to the center of the ankle joint, as confirmed by X-ray
- Is willing to be implanted with the Trammpolin® meniscus prosthesis.
- Is able to do the study required follow up visits, questionnaires, X-rays, CT-scans, and MRI's
- Is able and willing to understand and sign the study Informed Consent Form
- Is able to read and understand the national language of the country in which the relevant clinical site is located
Who cannot join
- Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy
- Has evidence of a modified Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a Trammpolin® meniscus prosthesis (e.g., a focal lesion > 0.5 cm2 correlating to a circular defect of > 8 mm in diameter)
- Has lateral compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the lateral compartment
- Has a varus or valgus knee deformity of > 5° requiring a tibial or femoral osteotomy
- Has a varus alignment that is not passively correctable
- Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL)
Show all 34Show fewer
- Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment
- Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the patellar compartment.
- Compared to a normal knee, has obvious radiological evidence of medial femoral squaring, anatomical variance in the medial tibial plateau, or irregularly shaped cartilage surface
- Had an ACL reconstruction performed < 9 months prior to surgery
- Has a BMI > 32.5 at the time of screening
- Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the Trammpolin® meniscus prosthesis
- Has a knee flexion contracture > 10°
- Has flexion < 90°
- Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)
- Has insufficiency fractures or avascular necrosis of the medial compartment
- Has an active infection or tumor (local or systemic)
- Has any type of knee joint inflammatory disease including Sjogren's syndrome
- Has neuropathic knee osteoarthropathy, also known as Charcot joint
- Has any medical condition that does not allow possible arthroscopy of the knee
- Has neurological deficit (sensory, motor, or reflex)
- Is currently involved in another investigation of the lower extremity
- Anticipates having another lower extremity surgery during the study period
- Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
- Has received any corticosteroid knee injections ≤ 3 months prior to surgery
- Has chondrocalcinosis
- Has proven osteoporosis
- Is on immunostimulating or immunosuppressing agents
- Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or KOOS (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a noticeable limp)
- Is a female who is lactating, expecting, or is intending to become pregnant during the study period
- Is an active smoker
- Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
- Is a prisoner
- Has a condition or be in a situation that, in the Investigator's opinion, may confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Maastricht UMC+
Maastricht, 6229 HX
Radboud UMC
Nijmegen, 6525 GA
Sint Maartenskliniek
Ubbergen, 6574 NA
About this study
Official title: Treatment of Medial Knee Joint Pain With the Trammpolin® Meniscus Prosthesis
The AIR Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® meniscus prosthesis system.
Read the detailed description
The Trammpolin® meniscus prosthesis is intended to replace the native medial meniscus to provide pain relief in the medial compartment of the knee joint, when this is caused by medial partial meniscectomy.
Patients who meet the inclusion/exclusion criteria and who are implanted with the Trammpolin® meniscus prosthesis will be followed for 2 years. The patient reported outcome measures for knee pain and function, and knee clinical condition by MRI and X-ray is assessed post-operative compared to pre-operative.
- Conditions
- Meniscectomy, Osteo Arthritis Knee
- Being tested
- Trammpolin® meniscus prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trammpolin® meniscus prosthesisDevice
Trammpolin® meniscus prosthesis is an anatomically shaped, synthetic medial meniscus replacement
| Study group | Role | What they receive |
|---|---|---|
| Trammpolin® meniscus prosthesis | Experimental | The patients will be implanted with the Trammpolin® meniscus prosthesis Receives: Device: Trammpolin® meniscus prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale
Performance of the Trammpolin® meniscus prosthesis in improving pain
Measured: 24 Months
Trammpolin® meniscus prosthesis device related complications
The nature and frequency of all adverse events observed during the study
Measured: 24 Months
Secondary outcomes (6)
KOOS Pain sub-scale
KOOS Pain sub-scale
Measured: 6 Weeks; 3, 6 and 12 Months
Overall KOOS scale
Overall KOOS scale
Measured: 6 Weeks; 3, 6, 12 and 24 Months
Lysholm scale
Lysholm scale
Measured: 6 Weeks; 3, 6, 12 and 24 Months
IKDC objective scale
IKDC objective scale
Measured: 6 Weeks; 3, 6, 12 and 24 Months
Knee X-ray
Joint space measurement
Measured: 6 Weeks; 12 and 24 Months
Knee MRI
Cartilage damage and extrusion
Measured: 12 and 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start11 Oct 2018
- Primary completion7 Jan 2021
- Study completion1 Jul 2021
Why it stopped: Halted prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeniscectomyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- ATRO Medical B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696836
- Sponsor's protocol ID
- AM-001
- Acronym
- AIR
- Status last verified
- Aug 2021
- First submitted
- 3 Oct 2018
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Medial Knee Joint Pain With the Trammpolin® Meniscus Prosthesis
- ClinicalTrials.gov ID
- NCT03696836
- Acronym / sponsor ID
- AIR / AM-001
- Conditions
- Meniscectomy, Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted prematurely
- Enrolment
- 5 participants (actual)
- Lead sponsor
- ATRO Medical B.V.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 5 Oct 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.
The AIR Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® meniscus prosthesis system.
Detailed description
The Trammpolin® meniscus prosthesis is intended to replace the native medial meniscus to provide pain relief in the medial compartment of the knee joint, when this is caused by medial partial meniscectomy.
Patients who meet the inclusion/exclusion criteria and who are implanted with the Trammpolin® meniscus prosthesis will be followed for 2 years. The patient reported outcome measures for knee pain and function, and knee clinical condition by MRI and X-ray is assessed post-operative compared to pre-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trammpolin® meniscus prosthesis | Experimental | Device: Trammpolin® meniscus prosthesisThe patients will be implanted with the Trammpolin® meniscus prosthesis |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has medial compartment joint pain with > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
- Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score)
- Is between age 30 and 65 years (inclusive) at the time of screening
- Has neutral alignment ± 5° of the mechanical axis, i.e., the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine to the center of the ankle joint, as confirmed by X-ray
- Is willing to be implanted with the Trammpolin® meniscus prosthesis.
Key exclusion criteria (34 listed)
- Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy
- Has evidence of a modified Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a Trammpolin® meniscus prosthesis (e.g., a focal lesion > 0.5 cm2 correlating to a circular defect of > 8 mm in diameter)
- Has lateral compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the lateral compartment
- Has a varus or valgus knee deformity of > 5° requiring a tibial or femoral osteotomy
- Has a varus alignment that is not passively correctable
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 |
|---|---|---|
| Trammpolin® meniscus prosthesisTrammpolin® meniscus prosthesis is an anatomically shaped, synthetic medial meniscus replacement | Device | Trammpolin® meniscus prosthesis |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale
Time frame: 24 Months
Performance of the Trammpolin® meniscus prosthesis in improving pain
Trammpolin® meniscus prosthesis device related complications
Time frame: 24 Months
The nature and frequency of all adverse events observed during the study
6 secondary outcomes
KOOS Pain sub-scale
Time frame: 6 Weeks; 3, 6 and 12 Months
Overall KOOS scale
Time frame: 6 Weeks; 3, 6, 12 and 24 Months
Lysholm scale
Time frame: 6 Weeks; 3, 6, 12 and 24 Months
IKDC objective scale
Time frame: 6 Weeks; 3, 6, 12 and 24 Months
Knee X-ray
Time frame: 6 Weeks; 12 and 24 Months
Knee MRI
Time frame: 12 and 24 Months
Results and safety
The study was stopped early (reason given: Halted prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Meniscectomy
RecruitingObservational study
Assessment of the Degree of Regeneration After Partial Meniscectomy Based on Thin-layer MRI Image Segmentation and Reconstruction
Meniscus Regeneration, Partial Meniscectomy
Recruiting
Novel Bioactive Sleeve on Pain and PROMs
Meniscus Tear
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
Recruiting
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
Chondral Lesion of the Knee, Meniscal Injuries
Active, not recruitingPhase 4
Corticosteroid Meniscectomy Randomized Trial
Osteoarthritis, Knee, Meniscus Tear
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trammpolin® meniscus prosthesis in people with Meniscectomy and Osteo Arthritis Knee, run by ATRO Medical B.V. at 3 sites 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 8 inclusion and 34 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: stopped early, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Halted prematurely). Results are not available in the source record.
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 injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale (time frame: 24 Months). The study lists 2 primary outcomes in all. 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 30 Aug 2021.