Hip, OsteoarthritisNCT06359301
H-34 DELTA Revision Cup
An observational study of Hip, Osteoarthritis, run by Limacorporate S.p.a at 1 site in Poland.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip, Osteoarthritis
- What is being tested?
- DELTA Revision acetabular cup
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 sitePoland
- Study dates
- 14 Sep 2021to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
Otwock, 05-400
Jerzy Bialecki
About this study
Official title: An Open Label, Observational, Prospective, Longitudinal Cohort Study to Evaluate Safety, Clinical and Radiographic Outcomes of Total Hip Arthroplasty With 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.
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.
- Conditions
- Hip, Osteoarthritis
- Being tested
- DELTA Revision acetabular cup
- Keywords
- revision
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DELTA Revision acetabular cupDevice
Total hip arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS)
Overall score from 0 to 100, with 100 being the best outcome
Measured: From preoperative to 2 years after surgery
Secondary outcomes (5)
ROM measurement
Functional changes in ROM measurements from pre-operative (baseline), discharge, 2 months, 6 months, 1 year and 2 years
Measured: From preoperative to 2 years after surgery
Oxforn Hip Score (OHS)
Overall score from 0 to 48, with 48 being the best outcome
Measured: From preoperative to 2 years after surgery
Survival rate
Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery
Measured: 2 years
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
Measured: From preoperative to 2 years after surgery
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
Measured: From preoperative to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start14 Sep 2021
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip, OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerzy Bialecki, Principal investigator, Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359301
- Sponsor's protocol ID
- H-34
- Status last verified
- Jan 2026
- First submitted
- 15 Mar 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Observational, Prospective, Longitudinal Cohort Study to Evaluate Safety, Clinical and Radiographic Outcomes of Total Hip Arthroplasty With DELTA Revision Cup
- ClinicalTrials.gov ID
- NCT06359301
- Acronym / sponsor ID
- H-34
- Conditions
- Hip, Osteoarthritis
- Keywords
- revision
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DELTA Revision acetabular cupTotal hip arthroplasty | Device | – |
Primary outcome
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
5 secondary outcomes
ROM measurement
Time frame: From preoperative to 2 years after surgery
Oxforn Hip Score (OHS)
Time frame: From preoperative to 2 years after surgery
Survival rate
Time frame: 2 years
Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup
Time frame: From preoperative to 2 years after surgery
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jerzy Bialecki principal investigator
Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip, Osteoarthritis, run by Limacorporate S.p.a at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federica Azzimonti (+39 377 5450940, federica.azzimonti@limacorporate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (HHS) (time frame: From preoperative to 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.