MINIMA Stem With DELTA TT or DELTA ST-C Study

A Prospective Randomized Clinical Study Evaluating the Outcomes of MINIMA Stem With DELTA TT or DELTA ST-C Cup After Total Hip Arthroplasty

This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.

This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.

Inclusion Criteria:

• Both genders
• Any race
• A diagnosis in the target hip of one or more of the following: a) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis; b) rheumatoid arthritis; c) post-traumatic arthritis; d) fractures of femoral neck;
• patien willingness to partecipate and signature of informed consent form

Exclusion Criteria:

• local or systemic infection
• septicaemia
• persistent acute or chronic osteomyelitis
• confirmed nerve or muscle lesion compromising hip joint function
• vascular or nerve disease affecting the concerned limb
• poor bone stock (for example due to osteoporosis) compromising the stability of the implant
• metabolic disorders which may impair fixation and stability of the implant
• any concomitant disease and dependence that might affect the implanted prosthsis
• metal hypersensitivity to implant materials
• required revision of previous standard femoral stem
• women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remail on an acceptable method of birth control throughout the entire study period
• life expectancy less than 5 years