Randomized MINIMA Stem with DELTA TT or DELTA ST-C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2029-02-15

Brief Summary

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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.

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Detailed Description

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

Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Minima Stem with ST-c Cup

Group Type OTHER

TT cup and ST-C cup

Intervention Type DEVICE

Patients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup)

Minima Stem with TT Cup

Group Type OTHER

TT cup and ST-C cup

Intervention Type DEVICE

Patients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup)

Interventions

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TT cup and ST-C cup

Patients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No