Osteoarthritis, Hip
Conditions
Brief 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.
Interventions
DEVICEDELTA Multihole TT
Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.
Sponsors
Limacorporate S.p.a
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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: 1. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery. 2. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ROM measurement | Pre-operative - Month 24 | Functional changes in the ROM measurements from pre-operative (baseline) to 2 years after surgery. |
| VAS Pain | Pre-operative - Month 24 | Changes in the VAS Pain score from pre-operative (baseline) to 2 years after surgery. |
| Implant stability | Month 24 | Radiographic implant evaluation and stability assessment at 2 years after surgery. |
| Survival rate | Month 24 | Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery |
| Safety assessment | Intra-operative, Week 2, Week 6, Month 6, Month 12, Month 24 | 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. |
Countries
Poland
Outcome results
None listed