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Recruiting

NCT Number: NCT06359301

H-34 DELTA Revision Cup

THis study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup.

Recruiting

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Key information

Conditions

Hip, Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP

Otwock, 05-400, Poland

Location status: Recruiting

Location contact

Jerzy Bialecki

CONTACT

About this study

This is an observational study designed to reflect real life clinical practice as closely as possible. Thus, clinicians are free to choose the method to implant and total hip arthroplasty in accordance with the current local Delta Revision acetabular cup Indication for Use and current clinical practice.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female in whom a decision has already been made to perform a total hip arthroplasty with DELTA Revision acetabular cup as per indication for use. The decision to implant DELTA revision acetabular cup must be taken prior to, and independently from the decision to enroll the patient. This decision should be made in accorsance with routine clinical practice at the study site concerned.
  • Age ≥ 18 years old
  • All patients mist give written informed consent approved by the study site's Institutinal Review Board (IRB)/Ethical Committee (EC)
  • Patient is able to comply with the protocol

Exclusion criteria

  • Adult patients with any DELTA Revision acetabular cup contraindication for use as reported in the current local instruction for use.
  • For female patiens, current pregnancy and/or lactation or planning a pregnancy

Treatment and study plan

DELTA Revision acetabular cup

Device

Total hip arthroplasty

Primary outcomes

  1. Harris Hip Score (HHS)

    Time frame: From preoperative to 2 years after surgery

    Overall score from 0 to 100, with 100 being the best outcome

Secondary outcomes

  1. ROM measurement

    Time frame: From preoperative to 2 years after surgery

    Functional changes in ROM measurements from pre-operative (baseline), discharge, 2 months, 6 months, 1 year and 2 years

  2. Oxforn Hip Score (OHS)

    Time frame: From preoperative to 2 years after surgery

    Overall score from 0 to 48, with 48 being the best outcome

  3. Survival rate

    Time frame: 2 years

    Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery

  4. Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup

    Time frame: From preoperative to 2 years after surgery

    The treated hip is analyzed postoperatively based on anteroposterior and lateral x-rays view of the knee to check for radiographic stability and radiographically detectable complications

  5. 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

    Time frame: From preoperative to 2 years after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Federica Azzimonti

CONTACT

[email protected]

+39 377 5450940

Sponsors and collaborators

Lead sponsor

Limacorporate S.p.a

Industry

Registry information

Official study title

An Open Label, Observational, Prospective, Longitudinal Cohort Study to Evaluate Safety, Clinical and Radiographic Outcomes of Total Hip Arthroplasty With DELTA Revision Cup

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Apr 11, 2024
Registry last updated
Jan 22, 2026

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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