H-29 DELTA Multihole TT Study.

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Device: DELTA Multihole TT

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Poland
  • Otwock, Poland, 05-400
    • Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population consists of 50 consecutive subjects who underwent a THA with the DELTA Multihole TT acetabular cup. Patients are screened for enrolment into the study from a list of patients who had a surgery at the Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP in 2019 onwards.

Subjects who do not meet all the inclusion criteria or meet any exclusion criteria are excluded from study participation and should be considered as a Screening Failure.

Subjects who meet all the inclusion criteria and none of the exclusion criteria and agree to participate in the study signing the Informed Consent Form are enrolled.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROM measurement	Functional changes in the ROM measurements from pre-operative (baseline) to 2 years after surgery.	Pre-operative - Month 24
VAS Pain	Changes in the VAS Pain score from pre-operative (baseline) to 2 years after surgery.	Pre-operative - Month 24
Implant stability	Radiographic implant evaluation and stability assessment at 2 years after surgery.	Month 24
Survival rate	Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery	Month 24
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

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a
• Investigators: Principal Investigator: Rafal Garlewicz, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): September 26, 2024
• Study Completion (Actual): September 26, 2024

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: H-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No