An interventional study of Trammpolin medial meniscus prosthesis in Knee Injuries and Disorders, sponsored by ATRO Medical B.V.. Status unknown at 3 sites in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-28.
Sponsored by ATRO Medical B.V. · Not applicable, Interventional, and Treatment
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.
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.
249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 160 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →ATRO Medical B.V. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Implantation of a medial meniscus prosthesis in the medial knee compartment of a post medial meniscectomy knee.
Device: Trammpolin medial meniscus prosthesis
Implantation of the Trammpolin medial meniscus prosthesis in patients with a severe medial meniscus damage
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
Time frame: 24 months
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.
Time frame: 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 .
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)
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"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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')
Time frame: 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
Time frame: 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).
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
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: L. 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.
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.
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.
Time frame: At implantation and if applicable at explantation
Safety of the Trammpolin® medial meniscus prosthesis
Incidence of adverse events (e.g. hospitalization)
Time frame: 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
Time frame: 6 weeks, 3 months, 6 months, 12 months and 24 months
Plan to share: No
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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ATRO Medical B.V.