Ankylosing Spondylitis, Avascular Necrosis, Congenital Dysplasia of the Hip, Injury of Hip, Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis
Conditions
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
Interventions
DEVICEMP-1 Polymer on Ceramic Articulation system
MP-1 Polymer liner on Ceramic head
Sponsors
M.M.A Tech Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
Yes
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical patient status according to Harris Score | 6 months | \>60 |
| Radiographic success | 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 |
Countries
Israel
Contacts
Primary ContactSimha Sibony
Outcome results
None listed