Osteoarthritis, HipNCT05014113
H-28 DELTA ST-C and Minima Retrospective Study.
An observational study of Osteoarthritis, Hip, run by Limacorporate S.p.a at 1 site in Greece.
Trial summary
The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant. 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-ST cup in combination with MINIMA stem
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 1 siteGreece
- Study dates
- 15 Sep 2020to 31 Mar 2022
- 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 95 consecutive patients who underwent to a THA with DELTA ST-C cup in combination with MINIMA stem in 2017 onwards at the Psychiko Clinic and are compliant with all the Inclusion and Exclusion criteria.
Who may be able to join
- Underwent to a THA with DELTA ST-C cup and MINIMA stem in 2017 onwards
- Both genders
- Any race
- A diagnosis in the target hip of one or more of the following:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis
- Rheumatoid Arthritis
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- Post-traumatic arthritis
- Fractures of femoral neck
- Congenital or acquired deformity
- Patient willingness to participate
Who cannot join
- Local or systemic infection
- Septicaemia
- Persistent acute or chronic osteomyelitis
- Confirmed nerve or muscle lesion compromising hip joint function
- Vascular or nerve diseases affecting the concerned limb
- Poor bone stock (for example due to osteoporosis) compromising the stability of the implant
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- Metabolic disorders which may impair fixation and stability of the implant
- Any concomitant disease and dependence that might affect the implanted prosthesis
- Metal hypersensitivity to implant materials
- Required revision of previous standard femoral stem
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Psychiko Clinic (Athens Medical Group)
Athens, Psychiko, 115 25
Angeliki Syrigou
Nikolaos Christodoulou
About this study
Official title: A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA ST-C Cup and MINIMA Stem.
The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant.
- Conditions
- Osteoarthritis, Hip
- Being tested
- DELTA-ST cup in combination with MINIMA stem
- 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-ST cup in combination with MINIMA stemDevice
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)
Assessment of Harris Hip Score from pre-operative baseline up to 3 years after surgery
Measured: Pre-operative - Month 36
Secondary outcomes (4)
Stability assessment of DELTA ST-C cup
Radiographic analysis and stability assessment of the DELTA ST-C cup as rate of symptomatic radiolucent lines, loosening, and subsidence ≥ 2 mm from discharge (baseline) up to 3-year follow-up
Measured: At discharge - Month 36
Stability assessment of MINIMA stem
Radiographic analysis and stability assessment of the MINIMA stem as rate of symptomatic radiolucent lines, loosening, and subsidence ≥ 2 mm from discharge (baseline) up to 3-year follow-up
Measured: At discharge - Month 36
Survival rate of the implant
The survival rate of the implant is expressed by Kaplan-Meier estimator
Measured: Month 36
Safety assessment (adverse events)
Assessment of any possible adverse device event or device-related complication detected and recorded
Measured: Intra-operative - Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start15 Sep 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
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
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014113
- Sponsor's protocol ID
- H-28
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. 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 ST-C Cup and MINIMA Stem.
- ClinicalTrials.gov ID
- NCT05014113
- Acronym / sponsor ID
- H-28
- Conditions
- Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 20 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.
The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant.
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 95 consecutive patients who underwent to a THA with DELTA ST-C cup in combination with MINIMA stem in 2017 onwards at the Psychiko Clinic and are compliant with all the Inclusion and Exclusion criteria.
Key inclusion criteria (10 listed)
- Underwent to a THA with DELTA ST-C cup and MINIMA stem in 2017 onwards
- Both genders
- Any race
- A diagnosis in the target hip of one or more of the following:
- Patient willingness to participate
Key exclusion criteria (16 listed)
- Local or systemic infection
- Septicaemia
- Persistent acute or chronic osteomyelitis
- Confirmed nerve or muscle lesion compromising hip joint function
- Vascular or nerve diseases affecting the concerned limb
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-ST cup in combination with MINIMA stemAdvance 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: Pre-operative - Month 36
Assessment of Harris Hip Score from pre-operative baseline up to 3 years after surgery
4 secondary outcomes
Stability assessment of DELTA ST-C cup
Time frame: At discharge - Month 36
Stability assessment of MINIMA stem
Time frame: At discharge - Month 36
Survival rate of the implant
Time frame: Month 36
Safety assessment (adverse events)
Time frame: Intra-operative - Month 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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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.
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 Greece.
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 10 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 20 Aug 2021. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabiana Pavan (+393485816391, fabiana.pavan@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: Pre-operative - Month 36). 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 20 Aug 2021.