Knee Injuries and DisordersAIR2NCT05297175
AIR (Artificial Implant to Restore the Medial Meniscus Function)2 Clinical Investigation
A study testing Trammpolin medial meniscus prosthesis in people with Knee Injuries and Disorders, run by ATRO Medical B.V. at 3 sites in Netherlands.
Trial summary
The AIR2 Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® medial meniscus prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Injuries and Disorders
- What is being tested?
- Trammpolin medial meniscus prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesNetherlands
- Study dates
- 19 Oct 2021to Dec 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has medial compartment knee pain and had a medial partial or total meniscectomy > 6 months ago. The lack of meniscus tissue is confirmed by patient history and MRI
- Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score)
- Is between age 18 and 70 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® medial meniscus prosthesis
- Is willing and able to comply to the clinical investigation required follow up visits, questionnaires, X-rays and MRI's
- Is able and willing to understand and sign the clinical investigation 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 potentially 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® medial meniscus prosthesis
- 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 29Show 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 > 30 at the time of screening
- Has a knee flexion contracture > 10°
- Has a knee flexion < 90°
- Had a previous High Tibial Osteotomy (HTO) < 1 year ago
- 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 clinical investigation period
- Has received any corticosteroid knee injections ≤ 3 months prior to surgery
- 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 clinical investigation period
- Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
- Has a condition or be in a situation that, in the Investigator's opinion, may confound the clinical investigation results, may risk the safety of the patient, or may interfere significantly with the subject's participation in the clinical investigation
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
MUMC+
Maastricht, 6229 HX
L. Jutten, +31 (0)43 387 7144, l.jutten@mumc.nl
P.J. Emans, MD. PhD
- Recruiting
Sint Maartenskliniek
Nijmegen, 6574 NA
P. Heesterbeek, PhD., +31(0)24 365 9628, p.heesterbeek@maartenskliniek.nl
S. Suzan, +31(0)24 365 9049, s.suzan@maartenskliniek.nl
- Recruiting
Haaglanden Medisch Centrum
The Hague, 2597 AX
E.R.A. van Arkel, MD., +31(0)88 979 5852, e.van.arkel@haaglandenmc.nl
E.R.A. van Arkel, MD.
About this study
Official title: Feasibility of the Trammpolin® Medial Meniscus Prosthesis Intended to Restore the Medial Meniscus Function to Provide Pain Relief After Meniscectomy
The AIR2 Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® medial meniscus prosthesis.
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® medial 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
- Knee Injuries and Disorders
- Being tested
- Trammpolin medial meniscus prosthesis
- Keywords
- Medial meniscus prosthesis, Symptomatic uni-compartmental pain
- Medical subject headings
- Knee Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trammpolin medial meniscus prosthesisDevice
Implantation of the Trammpolin medial meniscus prosthesis in patients with a severe medial meniscus damage
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Implantation of a medial meniscus prosthesis in the medial knee compartment of a post medial meniscectomy knee. Receives: Device: Trammpolin medial meniscus prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the Trammpolin® medial meniscus prosthesis
Performance of the Trammpolin® medial meniscus prosthesis in improving pain as assessed by the Knee Osteoarthritis and injury Outcome Score (KOOS) Pain Sub-scale at 24 months post-operative compared to baseline (pre-operative) The minimum value is 0 and maximum value is 100, a score of 100 is being no pain and the highest attainable score
Measured: 24 months
Secondary outcomes (13)
Knee Osteoarthritis and injury Outcome Score (KOOS) Pain
- Knee Osteoarthritis and injury Outcome Score (KOOS) Pain Sub-scale at 6 weeks, 3 months, 6 months, 12 and 24 months post-operative compared to baseline (pre-operative). A score of 100 is being no pain.
Measured: 6 weeks, 3 months, 6 months, 12 months and 24 months
Knee Osteoarthritis and injury Outcome Score (KOOS) overall
at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). A score of 100 is being no pain .
Measured: at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative).
PAIN Visual Analog Scale (VAS)
at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain"
Measured: at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative
Lysholm Knee Scoring Scale
scale at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative).
The Lysholm Knee Scoring Scale consists of eight items that asses: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support.
Measurement level per item: mode of scoring (0-25); measurement level ordinal Measurement level total score: mode of scoring (0-100); measurement level ordinal 100 = no symptoms of impairment. Higher scores indicate a better outcome with fewer symptoms or disability.
Measured: at 6 weeks, 3 months, 6 months, 12 months and 24 months
Oxford Knee Score
at 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative).
The Oxford Knee Score questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Measured: at 6, 12 and 24 months
Europol 5D health utility score
at 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative).
Evaluates the generic quality of life, developed in Europe and widely used. Used for estimating QALY to make decisions in resource allocation. The EQ-5D questionnaire has two components: health state description and evaluation. Health state is measured in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In the evaluation part, the respondents evaluate their overall health status using the VAS.
Measured: at 6, 12 and 24 months
Work, Osteoarthritis or joint-Replacement Questionnaire (WORQ)
at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). The questionnaire consists of 13 items and has a total score from 0 ('very much trouble/ can't do') to 100 ('no trouble at all')
Measured: at 6 weeks, 3 months, 6 months, 12 months and 24 months
Patient satisfaction on a 5-point Likert scale
at 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative).
The Likert scale consists of a series of statements about a topic, on which the respondent can indicate their level of agreement. For each item, a respondent is asked, using a series of ordered answer options, to indicate the extent to which he agrees with the statement, for example 'totally agree' or 'disagree'. The separate items together indicate the attitude of a respondent towards a subject. The questions uses a 5 or 7 point scale, from one extreme to the other. It is also called a satisfaction scale or satisfaction survey
Measured: at 6 months, 12 months and 24 months
Knee X-ray (weight-bearing)
To evaluate the height of the joint space compared to baseline (pre-operative).
Measured: 12 months
Knee MRI - Assessment of cartilage condition according to the modified Outerbridge Grading system at screening, 12 and 24 months - Assessment of relative position of the Trammpolin® medial meniscus prosthesis to the tibial plateau
Reference 24 CIP: (Jones) Assessment of relative position of the Trammpolin® medial meniscus prosthesis to the tibial plateau, i.e. "extrusion" will be performed according to the method as described by Jones:
- D. Jones, S. J. Mellon, N. Kruger, A. P. Monk, A. J. Price, and D. J. Beard, "Medial meniscal extrusion: a validation study comparing different methods of assessment," Knee Surg Sports Traumatol Arthrosc, Apr. 2017, doi: 10.1007/s00167-017-4544-4.
Measured: At 12 and 24 months
Biopsy of synovium and synovial fluid sample. In case the investigational device requires revision another biopsy is taken from the synovium and a second sample of the synovial fluid.
The baseline samples are stored in the freezer, to be used as baseline values in case the investigational device requires revision during the course of the study. During any secondary surgical procedure, another biopsy is taken from the synovium and a second sample of the synovial fluid. Samples will be compared in a qualitative/descriptive manner according to the method as described by Krenn in PATHOLOGY RESEARCH AND PRACTICE, 2002;198(5):317-25: hyperplasia/enlargement of synovial lining cell layer, inflammatory infiltration, activation of synovial stroma/pannus formation will be assessed. Synovial fluid samples at baseline will be compared to any later sample with respect to the presence and nature of foreign body particles.
Measured: At implantation and if applicable at explantation
Safety of the Trammpolin® medial meniscus prosthesis
Incidence of adverse events (e.g. hospitalization)
Measured: 6 weeks, 3 months, 6 months, 12 months and 24 months
Safety - Incidence of secondary surgery of the index knee
Incidence of secondary surgery of the index knee
Measured: 6 weeks, 3 months, 6 months, 12 months 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 posted28 Mar 2022
- Study start19 Oct 2021
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Injuries and DisordersStudies 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
- Model description
- Early feasibility study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ATRO Medical B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- T. van Tienen, MD. PhD., Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297175
- Sponsor's protocol ID
- AM-002
- Acronym
- AIR2
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 28 Mar 2022
- 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 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Trammpolin® Medial Meniscus Prosthesis Intended to Restore the Medial Meniscus Function to Provide Pain Relief After Meniscectomy
- ClinicalTrials.gov ID
- NCT05297175
- Acronym / sponsor ID
- AIR2 / AM-002
- Conditions
- Knee Injuries and Disorders
- Keywords
- Medial meniscus prosthesis, Symptomatic uni-compartmental pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ATRO Medical B.V.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Mar 2022 (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 AIR2 Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® medial meniscus prosthesis.
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® medial 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
- Model description
- Early feasibility study
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: Trammpolin medial meniscus prosthesisImplantation of a medial meniscus prosthesis in the medial knee compartment of a post medial meniscectomy knee. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has medial compartment knee pain and had a medial partial or total meniscectomy > 6 months ago. The lack of meniscus tissue is confirmed by patient history and MRI
- Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score)
- Is between age 18 and 70 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® medial meniscus prosthesis
Key exclusion criteria (29 listed)
- Has a symptomatic knee because of a tear that could potentially 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® medial meniscus prosthesis
- 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 medial meniscus prosthesisImplantation of the Trammpolin medial meniscus prosthesis in patients with a severe medial meniscus damage | Device | Single arm |
Primary outcome
Performance of the Trammpolin® medial meniscus prosthesis
Time frame: 24 months
Performance of the Trammpolin® medial meniscus prosthesis in improving pain as assessed by the Knee Osteoarthritis and injury Outcome Score (KOOS) Pain Sub-scale at 24 months post-operative compared to baseline (pre-operative) The minimum value is 0 and maximum value is 100, a score of 100 is being no pain and the highest attainable score
13 secondary outcomes
Knee Osteoarthritis and injury Outcome Score (KOOS) Pain
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Knee Osteoarthritis and injury Outcome Score (KOOS) overall
Time frame: at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative).
PAIN Visual Analog Scale (VAS)
Time frame: at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative
Lysholm Knee Scoring Scale
Time frame: at 6 weeks, 3 months, 6 months, 12 months and 24 months
Oxford Knee Score
Time frame: at 6, 12 and 24 months
Europol 5D health utility score
Time frame: at 6, 12 and 24 months
Work, Osteoarthritis or joint-Replacement Questionnaire (WORQ)
Time frame: at 6 weeks, 3 months, 6 months, 12 months and 24 months
Patient satisfaction on a 5-point Likert scale
Time frame: at 6 months, 12 months and 24 months
Knee X-ray (weight-bearing)
Time frame: 12 months
Knee MRI - Assessment of cartilage condition according to the modified Outerbridge Grading system at screening, 12 and 24 months - Assessment of relative position of the Trammpolin® medial meniscus prosthesis to the tibial plateau
Time frame: At 12 and 24 months
Biopsy of synovium and synovial fluid sample. In case the investigational device requires revision another biopsy is taken from the synovium and a second sample of the synovial fluid.
Time frame: At implantation and if applicable at explantation
Safety of the Trammpolin® medial meniscus prosthesis
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Safety - Incidence of secondary surgery of the index knee
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: No
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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.
T. van Tienen, MD. PhD. study director
Sponsor GmbH
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 medial meniscus prosthesis in people with Knee Injuries and Disorders, 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 29 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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact J. Lugies (+31650401596, jose.lugies@atromedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the Trammpolin® medial meniscus prosthesis (time frame: 24 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 28 Mar 2022.