AL-2 MP-1 (Polyimide) Acetabular Liner
Primary Purpose
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MP-1 Polymer on Ceramic Articulation system
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
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;
- 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.
Exclusion Criteria:
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;
- 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.
Sites / Locations
- Rambam HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Polymer on Ceramic
Arm Description
MP-1 Polymer on Ceramic articulation system
Outcomes
Primary Outcome Measures
Clinical patient status according to Harris Score
>60
Radiographic success
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02503891
Brief Title
AL-2 MP-1 (Polyimide) Acetabular Liner
Official Title
Total Hip Replacement - MP-1 Acetabular Liner
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.M.A Tech Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Congenital Dysplasia of the Hip, Ankylosing Spondylitis, Post-traumatic; Arthrosis, Injury of Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Polymer on Ceramic
Arm Type
Experimental
Arm Description
MP-1 Polymer on Ceramic articulation system
Intervention Type
Device
Intervention Name(s)
MP-1 Polymer on Ceramic Articulation system
Other Intervention Name(s)
AL-2 MP-1 Polyimide Acetabular liner
Intervention Description
MP-1 Polymer liner on Ceramic head
Primary Outcome Measure Information:
Title
Clinical patient status according to Harris Score
Description
>60
Time Frame
6 months
Title
Radiographic success
Description
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
Time Frame
3 mth , 12mth, 24 mth post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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;
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simha Sibony
Phone
+972-52-654-6625
Email
simha@mma-tech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simha Sibony
Organizational Affiliation
M.M.A Tech Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Rambam Hospital
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SIMHA SIBONY
Phone
+972-52-654-6625
Email
simha@mma-tech.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
mmatech website
Learn more about this trial
AL-2 MP-1 (Polyimide) Acetabular Liner
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