Back to resultsAIR (Artificial Implant to Restore the Medial Meniscus Function)2 Clinical Investigation (AIR2)
Primary Purpose
Knee Injuries and Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Trammpolin medial meniscus prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries and Disorders focused on measuring Medial meniscus prosthesis, Symptomatic uni-compartmental pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Sites / Locations
- Haaglanden Medisch CentrumRecruiting
- MUMC+Recruiting
- Sint MaartenskliniekRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm
Arm Description
Implantation of a medial meniscus prosthesis in the medial knee compartment of a post medial meniscectomy knee.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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 .
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"
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.
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.
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.
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')
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
Knee X-ray (weight-bearing)
To evaluate the height of the joint space compared to baseline (pre-operative).
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.
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.
Safety of the Trammpolin® medial meniscus prosthesis
Incidence of adverse events (e.g. hospitalization)
Safety - Incidence of secondary surgery of the index knee
Incidence of secondary surgery of the index knee
Full Information
NCT ID
NCT05297175
First Posted
February 14, 2022
Last Updated
March 16, 2022
Sponsor
ATRO Medical B.V.
Collaborators
Avania
1. Study Identification
Unique Protocol Identification Number
NCT05297175
Brief Title
AIR (Artificial Implant to Restore the Medial Meniscus Function)2 Clinical Investigation
Acronym
AIR2
Official Title
Feasibility of the Trammpolin® Medial Meniscus Prosthesis Intended to Restore the Medial Meniscus Function to Provide Pain Relief After Meniscectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ATRO Medical B.V.
Collaborators
Avania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries and Disorders
Keywords
Medial meniscus prosthesis, Symptomatic uni-compartmental pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Early feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Other
Arm Description
Implantation of a medial meniscus prosthesis in the medial knee compartment of a post medial meniscectomy knee.
Intervention Type
Device
Intervention Name(s)
Trammpolin medial meniscus prosthesis
Intervention Description
Implantation of the Trammpolin medial meniscus prosthesis in patients with a severe medial meniscus damage
Primary Outcome Measure Information:
Title
Performance of the Trammpolin® medial meniscus prosthesis
Description
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
Secondary Outcome Measure Information:
Title
Knee Osteoarthritis and injury Outcome Score (KOOS) Pain
Description
• 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
Title
Knee Osteoarthritis and injury Outcome Score (KOOS) overall
Description
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).
Title
PAIN Visual Analog Scale (VAS)
Description
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
Title
Lysholm Knee Scoring Scale
Description
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
Title
Oxford Knee Score
Description
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
Title
Europol 5D health utility score
Description
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
Title
Work, Osteoarthritis or joint-Replacement Questionnaire (WORQ)
Description
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
Title
Patient satisfaction on a 5-point Likert scale
Description
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
Title
Knee X-ray (weight-bearing)
Description
To evaluate the height of the joint space compared to baseline (pre-operative).
Time Frame
12 months
Title
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
Description
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
Title
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.
Description
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
Title
Safety of the Trammpolin® medial meniscus prosthesis
Description
Incidence of adverse events (e.g. hospitalization)
Time Frame
6 weeks, 3 months, 6 months, 12 months and 24 months
Title
Safety - Incidence of secondary surgery of the index knee
Description
Incidence of secondary surgery of the index knee
Time Frame
6 weeks, 3 months, 6 months, 12 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
J. Lugies
Phone
+31650401596
Email
jose.lugies@atromedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
A. Brinks
Phone
+31633665030
Email
anita.brinks@atromedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. van Tienen, MD. PhD.
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Haaglanden Medisch Centrum
City
Den Haag
ZIP/Postal Code
2597 AX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E.R.A. van Arkel, MD.
Phone
+31(0)88 979 5852
Email
e.van.arkel@haaglandenmc.nl
First Name & Middle Initial & Last Name & Degree
E.R.A. van Arkel, MD.
Facility Name
MUMC+
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L. Jutten
Phone
+31 (0)43 387 7144
Email
l.jutten@mumc.nl
First Name & Middle Initial & Last Name & Degree
P.J. Emans, MD. PhD
First Name & Middle Initial & Last Name & Degree
T. Boymans, MD. PhD
Facility Name
Sint Maartenskliniek
City
Nijmegen
ZIP/Postal Code
6574 NA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P. Heesterbeek, PhD.
Phone
+31(0)24 365 9628
Email
p.heesterbeek@maartenskliniek.nl
First Name & Middle Initial & Last Name & Degree
S. Suzan
Phone
+31(0)24 365 9049
Email
s.suzan@maartenskliniek.nl
First Name & Middle Initial & Last Name & Degree
K.C. Defoort, MD.
12. IPD Sharing Statement
Plan to Share IPD
No
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AIR (Artificial Implant to Restore the Medial Meniscus Function)2 Clinical Investigation
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