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OpenTrials
Active, Not Recruiting

NCT Number: NCT06870123

Randomized MINIMA Stem with DELTA TT or DELTA ST-C

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Orthopedic Clinic University Hospital Martin

Martin, 036 59, Slovakia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Harris Hip Score (HHS)

    Time frame: 3 years

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

Secondary outcomes

  1. Harris Hip Score (HHS)

    Time frame: 5 years

    Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 5 years after surgery

  2. Implant stability

    Time frame: 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

  3. Oxford Hip Score (OHS)

    Time frame: 5 years

    Functional changes in Oxford Hip Score (OHS) from preoperative (baseline) to 5 years after surgery

  4. Forgotten Joint Score (FJS)

    Time frame: 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

  5. Survival Rate

    Time frame: 5 years

    Survival rate expressed with Kaplan-Meier estimator at 5 years after surgery

  6. Safety assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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