OsteoarthritisNCT02503891
AL-2 MP-1 (Polyimide) Acetabular Liner
A study testing MP-1 Polymer on Ceramic Articulation system in people with Osteoarthritis and Avascular Necrosis, run by M.M.A Tech Ltd. at 1 site in Israel.
Trial summary
M.M.A.TECH Ltd. product is an Acetabular Liner Family produced of an advanced polyimide - MP-1™. M.M.A.TECH Ltd. produces the Liners according to EN ISO 13485:2012 approved manufacturing process and supplies them to the customer. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- What is being tested?
- MP-1 Polymer on Ceramic Articulation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Sep 2017to Aug 2020
- 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 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria for subject participation in the study are:
- (Patient must meet all of the following characteristics to be enrolled in the study):
- Males and females, 21 to 90 years of age, inclusive;
- Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously;
- The patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form;
- The patient will be available for follow-up through at least two years postoperative;
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- The patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (FDA requirement);
- The patient has a total Harris Hip Score of less than or equal to 60 (FDA requirement);
- The patient meets none of the exclusion criteria.
Who cannot join
- with any of the following characteristics must be excluded from the study):
- Patients known to have insufficient quantity or quality of bone support resulting from Conditions such as cancer, femoral osteotomy, Girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. Patients with physical conditions tending to place extreme loads on implants such as morbid obesity (> 100 pounds over desirable body weight), Charcot joints, muscle deficiencies, or multiple joint disabilities;
- Patients with active localized or systemic infection;
- Patients who have not reached full skeletal maturity;
- Patient has had a total knee arthroplasty of either leg
- Patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions;
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- The patient is participating in any other pharmaceutical, biologic or medical device clinical investigation;
- Immunosuppressive disorders - immunosuppressive disorders are chronic conditions characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients receiving therapy to prevent homograft rejection, patients who have acquired immunodeficiency syndrome (AIDS), or auto-immune diseases (except rheumatoid arthritis).
- Pregnancy.
- Patients with known sensitivity to materials in the device.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Hospital
Haifa
SIMHA SIBONY, +972-52-654-6625, simha@mma-tech.com
About this study
Official title: Total Hip Replacement - MP-1 Acetabular Liner
M.M.A.TECH Ltd. product is an Acetabular Liner Family produced of an advanced polyimide - MP-1™.
M.M.A.TECH Ltd. produces the Liners according to EN ISO 13485:2012 approved manufacturing process and supplies them to the customer.
The aim of this study is to evaluate, in the frame of PMCF, the safety and performance of using AL-X MP1 Polyimide Acetabular liners in Total Hip Replacement surgery by clinical following up of patients for a period of 2 years .
Read the detailed description
The procedure involves removal of the diseased parts of the joint, that is the damaged cartilage and adjacent bone, and replacing them with artificial parts which closely resemble in structure and/or function the removed native parts.
The artificial parts fit onto the reshaped bone and are fixed either with bone cement (e.g., polymethylmethacrylate) and press fit of the part(cemented), or by self-anchorage with bone ingrowth to its porous surface(cementless).
The design of the artificial parts may include a stem, a keel or pegs, which fit onto the medullary canal of the bone or into a hole pre-prepared in the bone. An artificial part may fit loosely and be fixed with bone cement, press-fit for self- anchorage or include extendible anchors which are retracted upon placement and extended thereafter so as to secure the implant in place.
Following fixation of the components, the joint is reduced and the soft tissue tension is appropriately checked to reassure stability of the joint.
The MP-1™ acetabular liner will be tapper locked in acetabular metal shells to resurface the acetabular socket in cementless total hip replacement.
MMaTech Ltd will manufacture the liners to perfectly fit into the external metallic shell of the following sizes (mm):
LINER CUP SIZE LINER SIZE HEAD Liner thickness AL-2MP132040 44-48 32 ID 40 OD 32 4 mm AL-2MP136044 50-54 36 ID 44 OD 36 4mm AL-2MP136048 56-66 36 ID 48 OD 36 6mm AL-2MP140048 56-66 40 ID 48 OD 40 4mm
The MP-1™ Acteabular liners are intended to be used only against ceramic femoral heads- Biolox Delta
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Congenital Dysplasia of the Hip, Ankylosing Spondylitis, Post-traumatic; Arthrosis
- Being tested
- MP-1 Polymer on Ceramic Articulation system
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid, Hip Dislocation, Congenital, Spondylitis, Ankylosing, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP-1 Polymer on Ceramic Articulation systemDevice
Also called AL-2 MP-1 Polyimide Acetabular liner
MP-1 Polymer liner on Ceramic head
| Study group | Role | What they receive |
|---|---|---|
| Polymer on Ceramic | Experimental | MP-1 Polymer on Ceramic articulation system Receives: Device: MP-1 Polymer on Ceramic Articulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical patient status according to Harris Score
>60
Measured: 6 months
Radiographic success
- Radiographic success will be determined by femoral subsidence < 2mm, acetabular migration < 2mm, cup inclination < 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating
Measured: 3 mth , 12mth, 24 mth post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study start15 Sep 2017
- Primary completionSep 2018 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.M.A Tech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simha Sibony, Study chair, M.M.A Tech Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503891
- Sponsor's protocol ID
- MA-01
- Status last verified
- Dec 2017
- First submitted
- 14 Jul 2015
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: mmatech website
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Hip Replacement - MP-1 Acetabular Liner
- ClinicalTrials.gov ID
- NCT02503891
- Acronym / sponsor ID
- MA-01
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Congenital Dysplasia of the Hip, Ankylosing Spondylitis, Post-traumatic; Arthrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- M.M.A Tech Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 21 Jul 2015 (estimated)
- 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.
M.M.A.TECH Ltd. product is an Acetabular Liner Family produced of an advanced polyimide - MP-1™.
M.M.A.TECH Ltd. produces the Liners according to EN ISO 13485:2012 approved manufacturing process and supplies them to the customer.
The aim of this study is to evaluate, in the frame of PMCF, the safety and performance of using AL-X MP1 Polyimide Acetabular liners in Total Hip Replacement surgery by clinical following up of patients for a period of 2 years .
Detailed description
The procedure involves removal of the diseased parts of the joint, that is the damaged cartilage and adjacent bone, and replacing them with artificial parts which closely resemble in structure and/or function the removed native parts.
The artificial parts fit onto the reshaped bone and are fixed either with bone cement (e.g., polymethylmethacrylate) and press fit of the part(cemented), or by self-anchorage with bone ingrowth to its porous surface(cementless).
The design of the artificial parts may include a stem, a keel or pegs, which fit onto the medullary canal of the bone or into a hole pre-prepared in the bone. An artificial part may fit loosely and be fixed with bone cement, press-fit for self- anchorage or include extendible anchors which are retracted upon placement and extended thereafter so as to secure the implant in place.
Following fixation of the components, the joint is reduced and the soft tissue tension is appropriately checked to reassure stability of the joint.
The MP-1™ acetabular liner will be tapper locked in acetabular metal shells to resurface the acetabular socket in cementless total hip replacement.
MMaTech Ltd will manufacture the liners to perfectly fit into the external metallic shell of the following sizes (mm):
LINER CUP SIZE LINER SIZE HEAD Liner thickness AL-2MP132040 44-48 32 ID 40 OD 32 4 mm AL-2MP136044 50-54 36 ID 44 OD 36 4mm AL-2MP136048 56-66 36 ID 48 OD 36 6mm AL-2MP140048 56-66 40 ID 48 OD 40 4mm
The MP-1™ Acteabular liners are intended to be used only against ceramic femoral heads- Biolox Delta
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polymer on Ceramic | Experimental | Device: MP-1 Polymer on Ceramic Articulation systemMP-1 Polymer on Ceramic articulation system |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females, 21 to 90 years of age, inclusive;
- Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously;
- The patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form;
- The patient will be available for follow-up through at least two years postoperative;
- The patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (FDA requirement);
Key exclusion criteria (10 listed)
- Patients known to have insufficient quantity or quality of bone support resulting from Conditions such as cancer, femoral osteotomy, Girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. Patients with physical conditions tending to place extreme loads on implants such as morbid obesity (> 100 pounds over desirable body weight), Charcot joints, muscle deficiencies, or multiple joint disabilities;
- Patients with active localized or systemic infection;
- Patients who have not reached full skeletal maturity;
- Patient has had a total knee arthroplasty of either leg
- Patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions;
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 |
|---|---|---|
| MP-1 Polymer on Ceramic Articulation systemAlso: AL-2 MP-1 Polyimide Acetabular linerMP-1 Polymer liner on Ceramic head | Device | Polymer on Ceramic |
Primary outcome
Clinical patient status according to Harris Score
Time frame: 6 months
>60
Radiographic success
Time frame: 3 mth , 12mth, 24 mth post-surgery
o Radiographic success will be determined by femoral subsidence < 2mm, acetabular migration < 2mm, cup inclination < 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Individual participant dataSharing planned: Yes. mmatech website
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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.
Simha Sibony study chair
M.M.A Tech Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MP-1 Polymer on Ceramic Articulation system in people with Osteoarthritis and Avascular Necrosis, run by M.M.A Tech Ltd. at 1 site in Israel.
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 9 inclusion and 10 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 20 Dec 2017. 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 Israel. 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 Simha Sibony (+972-52-654-6625, simha@mma-tech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical patient status according to Harris Score (time frame: 6 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 20 Dec 2017.