Osteoarthritis, HipNCT05007067
H-29 DELTA Multihole TT Study.
An observational study of Osteoarthritis, Hip, 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 50 suitable subjects who underwent a complex primary or a revision Total Hip Arthroplasties with DELTA Multihole TT acetabular cup in 2019 onwards. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- DELTA Multihole TT
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 sitePoland
- Study dates
- 22 Feb 2022to 26 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 consecutive subjects who underwent a THA with the DELTA Multihole TT acetabular cup. Patients are screened for enrolment into the study from a list of patients who had a surgery at the Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP in 2019 onwards. 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 subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, as per indications for use, in 2019 onwards
- Age ≥ 18 years old
- Subjects who have signed the written informed consent approved by the reference Ethics Committee (EC)
- Subjects able to comply with the protocol and to perform all scheduled follow-up visits
Who cannot join
- Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, but showed any of the contraindications reported in the Instruction for Use
- Age < 18 years old
- Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to:
- significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery.
- neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device.
- known metabolic disorders leading to progressive bone deterioration.
- Hip replacement on the contralateral side performed within less than one year.
- Female subjects who are pregnant, nursing or planning a pregnancy.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
Otwock, 05-400
About this study
Official title: A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA Multihole TT Acetabular Cup.
This study is aimed to provide a clinical and radiographic evaluation of 50 suitable subjects who underwent a complex primary or a revision Total Hip Arthroplasties with DELTA Multihole TT acetabular cup in 2019 onwards.
- Conditions
- Osteoarthritis, Hip
- Being tested
- DELTA Multihole TT
- 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 Multihole TTDevice
Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS)
The percentage of subjects showing a Harris Hip Score (HHS) equal or greater than "Good" (i.e. equal or greater than 80 points) at 2 years after the surgery.
Measured: Month 24
Secondary outcomes (5)
ROM measurement
Functional changes in the ROM measurements from pre-operative (baseline) to 2 years after surgery.
Measured: Pre-operative - Month 24
VAS Pain
Changes in the VAS Pain score from pre-operative (baseline) to 2 years after surgery.
Measured: Pre-operative - Month 24
Implant stability
Radiographic implant evaluation and stability assessment at 2 years after surgery.
Measured: Month 24
Survival rate
Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery
Measured: Month 24
Safety assessment
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: Intra-operative, Week 2, Week 6, Month 6, Month 12, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start22 Feb 2022
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
Why it stopped: Lack of progress in fulfilling the Study activities, including the lack of enrollment of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rafal Garlewicz, Principal investigator, Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007067
- Sponsor's protocol ID
- H-29
- Status last verified
- Feb 2025
- First submitted
- 9 Aug 2021
- Last updated
- 24 Feb 2025
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA Multihole TT Acetabular Cup.
- ClinicalTrials.gov ID
- NCT05007067
- Acronym / sponsor ID
- H-29
- Conditions
- Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of progress in fulfilling the Study activities, including the lack of enrollment of participants
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 16 Aug 2021 (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 50 suitable subjects who underwent a complex primary or a revision Total Hip Arthroplasties with DELTA Multihole TT acetabular cup in 2019 onwards.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
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 50 consecutive subjects who underwent a THA with the DELTA Multihole TT acetabular cup. Patients are screened for enrolment into the study from a list of patients who had a surgery at the Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP in 2019 onwards. 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 subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, as per indications for use, in 2019 onwards
- Age ≥ 18 years old
- Subjects who have signed the written informed consent approved by the reference Ethics Committee (EC)
- Subjects able to comply with the protocol and to perform all scheduled follow-up visits
Key exclusion criteria (8 listed)
- Male or female subjects who underwent a Total Hip Arthroplasty with Delta Multihole TT acetabular cup, but showed any of the contraindications reported in the Instruction for Use
- Age < 18 years old
- Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to:
- Hip replacement on the contralateral side performed within less than one year.
- Female subjects who are pregnant, nursing 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 Multihole TTAdvance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity. | Device | – |
Primary outcome
Harris Hip Score (HHS)
Time frame: Month 24
The percentage of subjects showing a Harris Hip Score (HHS) equal or greater than "Good" (i.e. equal or greater than 80 points) at 2 years after the surgery.
5 secondary outcomes
ROM measurement
Time frame: Pre-operative - Month 24
VAS Pain
Time frame: Pre-operative - Month 24
Implant stability
Time frame: Month 24
Survival rate
Time frame: Month 24
Safety assessment
Time frame: Intra-operative, Week 2, Week 6, Month 6, Month 12, Month 24
Results and safety
The study was stopped early (reason given: Lack of progress in fulfilling the Study activities, including the lack of enrollment of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- 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. This study is not recruiting at the moment.
Rafal Garlewicz 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 Osteoarthritis, Hip, 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 8 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: stopped early, as of the sponsor's last update on 24 Feb 2025. 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?
The study was stopped early (reason given: Lack of progress in fulfilling the Study activities, including the lack of enrollment of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (HHS) (time frame: Month 24). 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 24 Feb 2025.