Randomized MINIMA Stem with DELTA TT or DELTA ST-C

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis, Hip

• Registration Number: NCT06870123
• Lead Sponsor: Limacorporate S.p.a

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-02-15
• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Primary Completion: 2027-02-15
• Study Completion: 2029-02-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Harris Hip Score (HHS)	3 years	Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery

Secondary Outcome Measures

Name	Time	Method
Safety assessment	Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years	Incidence, type, and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up.
Harris Hip Score (HHS)	5 years	Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 5 years after surgery
Implant stability	6 months, 1 year, 3 years, 5 years after surgery	Radiographic implant evaluation and stability assessment at 6 months, 1 year, 3 years, 5 years after surgery
Oxford Hip Score (OHS)	5 years	Functional changes in Oxford Hip Score (OHS) from preoperative (baseline) to 5 years after surgery
Survival Rate	5 years	Survival rate expressed with Kaplan-Meier estimator at 5 years after surgery
Forgotten Joint Score (FJS)	3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery	Changes in Forgotten Joint Score (FJS) from 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery

Trial Locations

Locations (1)

The Orthopedic Clinic University Hospital Martin; 🇸🇰 Martin, Slovakia