H-29 DELTA Multihole TT Study.

Osteoarthritis, Hip Clinical Trial

Official title:

A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA Multihole TT Acetabular Cup.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05007067
• Other study ID #: H-29
• Status: Recruiting
• Start date: February 22, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Limacorporate S.p.a
• Contact: Federica Azzimonti
• Phone: +39 377 5450940
• Email: federica.azzimonti[@]limacorporate.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• DELTA Multihole TT
Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.

Locations

Country	Name	City	State
Poland	Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP	Otwock

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score (HHS)	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.	Month 24
Secondary	ROM measurement	Functional changes in the ROM measurements from pre-operative (baseline) to 2 years after surgery.	Pre-operative - Month 24
Secondary	VAS Pain	Changes in the VAS Pain score from pre-operative (baseline) to 2 years after surgery.	Pre-operative - Month 24
Secondary	Implant stability	Radiographic implant evaluation and stability assessment at 2 years after surgery.	Month 24
Secondary	Survival rate	Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery	Month 24
Secondary	Safety assessment	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.	Intra-operative, Week 2, Week 6, Month 6, Month 12, Month 24