Hip OsteoarthritisNCT04375345
DELTA Multihole TT Study
An observational study of Hip Osteoarthritis and Arthroplasty Complications, run by University Hospital Bratislava at 1 site in Slovakia.
Trial summary
A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Arthroplasty Complications, Hip Dysplasia
- What is being tested?
- hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSlovakia
- Study dates
- 23 Jan 2020to 23 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: Study participants will be selected from patients who underwent a Total Hip Arthroplasty with the DELTA Multihole TT cup. Both complex primary and revision cases are considered.
IInclusion criteria as per DELTA Multihole TT indications for use:
Age ≥ 18 years
- Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis;
- Signed Informed consent
- Hip dislocation using protruded liners, spacers;
- Rheumatoid arthritis;
- Post-traumatic arthritis;
- Correction of functional deformity in case of acetabulum verticalization, anteversion, and retroversion;
- Fractures of femoral neck;
If used in combination with spacers and hemispheric modules, other indications are:
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure;
- Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results;
- Where bone stock is of poor quality or is inadequate for other reconstruction techniques as indicated by deficiencies of the acetabulum.
Exclusion criteria as per DELTA Multihole TT contraindications for use:
- Local or systemic infections;
- 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 compromising the stability of the implant;
- 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.
Additional exclusion criteria:
- Female patients who are pregnant, nursing, or planning a pregnancy.
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
2nd University Department of Orthopaedic and Trauma Surgery Comenius University Faculty of Medicine
Bratislava, 85107
About this study
Official title: A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty and Revision Hip Arthroplasty With DELTA Multihole TT Cup.
A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.
- Being tested
- hip arthroplasty
- Keywords
- total hip arthroplasty, hip arthroplasty revision, complex primary arthroplasty, trabecular titanium
- Medical subject headings
- Osteoarthritis, Hip, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip arthroplastyDevice
Also called revision hip arthroplasty
complex primary total hip arthroplasty or revision total hip arthroplasty performed through anterolateral or posterolateral approach
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of HHS score equal or greater than "Good" at 2 years after surgery
Measured: Month 24
Secondary outcomes (4)
Radiographic implant evaluation and stability assessment
Migration over 2 mm or over 5 degrees
Measured: Week 6, Week 12, Month 6, Month 12, Month 24
Survival rate
Kaplan-Meier
Measured: Month 24
Patients recovery at 2 years after surgery evaluated using the 5-level EQ-5D version (EQ-5D-5L).
The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
Measured: Month 24
Incidence of device-related Adverse Events / Serious Adverse Events
Measured: Intraoperative, Week 6, Week 12, 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 posted5 May 2020
- Study start23 Jan 2020
- Primary completion23 Jan 2022 (estimated)
- Study completion23 Mar 2022 (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
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bratislava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris Steno, University Hospital Bratislava
- Investigators
- Boris Steno, MD PhD Prof, Principal investigator, University Hospital Bratislava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375345
- Sponsor's protocol ID
- UHBratislava
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 5 May 2020
- 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 5 May 2020. 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 and Revision Hip Arthroplasty With DELTA Multihole TT Cup.
- ClinicalTrials.gov ID
- NCT04375345
- Acronym / sponsor ID
- UHBratislava
- Keywords
- total hip arthroplasty, hip arthroplasty revision, complex primary arthroplasty, trabecular titanium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital BratislavaUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 23 Jan 2022 (estimated)
- Study completion
- 23 Mar 2022 (estimated)
- First posted
- 5 May 2020 (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.
A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from patients who underwent a Total Hip Arthroplasty with the DELTA Multihole TT cup. Both complex primary and revision cases are considered.
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 |
|---|---|---|
| hip arthroplastyAlso: revision hip arthroplastycomplex primary total hip arthroplasty or revision total hip arthroplasty performed through anterolateral or posterolateral approach | Device | – |
Primary outcome
Percentage of HHS score equal or greater than "Good" at 2 years after surgery
Time frame: Month 24
4 secondary outcomes
Radiographic implant evaluation and stability assessment
Time frame: Week 6, Week 12, Month 6, Month 12, Month 24
Survival rate
Time frame: Month 24
Patients recovery at 2 years after surgery evaluated using the 5-level EQ-5D version (EQ-5D-5L).
Time frame: Month 24
Incidence of device-related Adverse Events / Serious Adverse Events
Time frame: Intraoperative, Week 6, Week 12, Month 6, Month 12, Month 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- 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.
Boris Steno, MD PhD Prof principal investigator
University Hospital Bratislava
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 and Arthroplasty Complications, run by University Hospital Bratislava at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 May 2020. 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 Slovakia. 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 Boris Steno, MD PhD Prof (+421905512004, bosten1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of HHS score equal or greater than "Good" at 2 years after surgery (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 5 May 2020; AzTrials last refreshed its copy on 26 Oct 2026.