Arthroplasty Complications, Hip Dysplasia, Hip Osteoarthritis
Conditions
Keywords
total hip arthroplasty, hip arthroplasty revision, complex primary arthroplasty, trabecular titanium
Brief summary
A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.
Interventions
DEVICEhip arthroplasty
complex primary total hip arthroplasty or revision total hip arthroplasty performed through anterolateral or posterolateral approach
Sponsors
University Hospital Bratislava
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of HHS score equal or greater than Good at 2 years after surgery | Month 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic implant evaluation and stability assessment | Week 6, Week 12, Month 6, Month 12, Month 24 | Migration over 2 mm or over 5 degrees |
| Survival rate | Month 24 | Kaplan-Meier |
| Patients recovery at 2 years after surgery evaluated using the 5-level EQ-5D version (EQ-5D-5L). | Month 24 | The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). |
| Incidence of device-related Adverse Events / Serious Adverse Events | Intraoperative, Week 6, Week 12, Month 6, Month 12, Month 24 | — |
Countries
Slovakia
Contacts
Primary ContactBoris Steno, MD PhD Prof
Backup ContactIlja Chandoga, MD PhD
Outcome results
None listed