H-29 DELTA Multihole TT Study.

Terminated

• Conditions: Osteoarthritis, Hip

• Registration Number: NCT05007067
• Lead Sponsor: Limacorporate S.p.a

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-16
• Study Start: 2022-02-22
• Primary Completion: 2024-09-26
• Study Completion: 2024-09-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ROM measurement	Pre-operative - Month 24	Functional changes in the ROM measurements from pre-operative (baseline) to 2 years after surgery.
Survival rate	Month 24	Survival rate expressed with Kaplan-Meier estimator at 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.
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.

Trial Locations

Locations (1)

Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP; 🇵🇱 Otwock, Poland