Randomized MINIMA Stem with DELTA TT or DELTA ST-C

Limacorporate

Status

Active, not recruiting

Conditions

Osteoarthritis, Hip

Treatments

Device: TT cup and ST-C cup

Study type

Interventional

Funder types

Industry

Identifiers

NCT06870123

H-41

Details and patient eligibility

About

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.

Full description

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

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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