Clinical trial NCT04375345: DELTA Multihole TT 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Osteoarthritis
Arthroplasty Complications
Hip Dysplasia
Keywords: total hip arthroplasty
hip arthroplasty revision
complex primary arthroplasty
trabecular titanium
Lead sponsor: University Hospital Bratislava
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of HHS score equal or greater than "Good" at 2 years after surgery
timeFrame: Month 24
Secondary outcomes:
measure: Radiographic implant evaluation and stability assessment
timeFrame: Week 6, Week 12, Month 6, Month 12, Month 24
measure: Survival rate
timeFrame: Month 24
measure: Patients recovery at 2 years after surgery evaluated using the 5-level EQ-5D version (EQ-5D-5L).
timeFrame: Month 24
measure: Incidence of device-related Adverse Events / Serious Adverse Events
timeFrame: Intraoperative, Week 6, Week 12, Month 6, Month 12, Month 24
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: 2nd University Department of Orthopaedic and Trauma Surgery Comenius University Faculty of Medicine
Study officials:
affiliation: University Hospital Bratislava
name: Boris Steno, MD PhD Prof
role: PRINCIPAL_INVESTIGATOR
References: