Randomized MINIMA Stem with DELTA TT or DELTA ST-C

NCT06870123 | Active Not Recruiting

• 1 other identifier: H-41
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score (HHS)

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

  3 years

Secondary Outcomes (6)

• Harris Hip Score (HHS)

  5 years

• Implant stability

  6 months, 1 year, 3 years, 5 years after surgery

• Oxford Hip Score (OHS)

  5 years

• Forgotten Joint Score (FJS)

  3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery

• Survival Rate

  5 years

Study Arms (2)

Minima Stem with ST-c Cup

OTHER

Minima Stem with ST-c Cup

Device: TT cup and ST-C cup

Minima Stem with TT Cup

OTHER

Minima Stem with TT Cup

Device: TT cup and ST-C cup

Interventions

TT cup and ST-C cup DEVICE

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

Minima Stem with ST-c Cup; Minima Stem with TT Cup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

The Orthopedic Clinic University Hospital Martin

Martin, 036 59, Slovakia

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: February 15, 2022
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2029
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)