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RecruitingNCT06359301Updated Jan 22, 2026

H-34 DELTA Revision Cup

An observational study in Hip, Osteoarthritis, sponsored by Limacorporate S.p.a. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Limacorporate S.p.a · Observational

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
49
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Hip, Osteoarthritis

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Keywords

  • revision
03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's planned enrollment of 49 is below the median of 141 across 154 observational studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Limacorporate S.p.a is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population consists of 49 consecutive subjects who underwent a THA with the DELTA Revision acetabular cup at the Independent Public Clinical Hospital Prof. Adama Grucy CMKP.

Subjects who do not meet all the inclusion criteria or meet any exclusion criteria are excluded from study participation and should be considered as a Screening Failure.

Subjects who meet all the inclusion criteria and none of the exclusion criteria and agree to participate in the study signing the Informed Consent Form are enrolled.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
49 participants (estimated)
Patient registry
No

Interventions

  • DeviceDELTA Revision acetabular cup

    Total hip arthroplasty

06

What researchers measure

Primary outcomes

  1. Harris Hip Score (HHS)

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

    Time frame: From preoperative to 2 years after surgery

Secondary outcomes

  1. ROM measurement

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

    Time frame: From preoperative to 2 years after surgery

  2. Oxforn Hip Score (OHS)

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

    Time frame: From preoperative to 2 years after surgery

  3. Survival rate

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

    Time frame: 2 years

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

    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

    Time frame: From preoperative to 2 years after surgery

  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

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Study locations

1 of 1 sites recruiting
  • Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
    Otwock, 05-400, Poland
    • Jerzy Bialecki · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06359301
Lead sponsor
Limacorporate S.p.a
Responsible party
Sponsor
First posted
Apr 11, 2024
Start date
Sep 14, 2021
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 22, 2026

Study contacts

Federica Azzimonti
Contact
federica.azzimonti@limacorporate.com
+39 377 5450940
Jerzy Bialecki
principal investigator · Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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