AL-2 MP-1 (Polyimide) Acetabular Liner
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|ClinicalTrials.gov Identifier: NCT02503891|
Recruitment Status : Recruiting
First Posted : July 21, 2015
Last Update Posted : December 20, 2017
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 .
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Congenital Dysplasia of the Hip Ankylosing Spondylitis Post-traumatic; Arthrosis Injury of Hip||Device: MP-1 Polymer on Ceramic Articulation system||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Total Hip Replacement - MP-1 Acetabular Liner|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||August 2020|
Experimental: Polymer on Ceramic
MP-1 Polymer on Ceramic articulation system
Device: MP-1 Polymer on Ceramic Articulation system
MP-1 Polymer liner on Ceramic head
Other Name: AL-2 MP-1 Polyimide Acetabular liner
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503891
|Contact: Simha Sibonyfirstname.lastname@example.org|
|Contact: SIMHA SIBONY +972-52-654-6625 email@example.com|
|Study Chair:||Simha Sibony||M.M.A Tech Ltd.|