H-29 DELTA Multihole TT Study.

NCT05007067 | Terminated

• 1 other identifier: H-29
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• ROM measurement

  Pre-operative - Month 24

• VAS Pain

  Pre-operative - Month 24

• Implant stability

  Month 24

• Survival rate

  Month 24

• Safety assessment

  Intra-operative, Week 2, Week 6, Month 6, Month 12, Month 24

Interventions

DELTA Multihole TT DEVICE

Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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:
• significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery.
• neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device.
• 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.

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP

Otwock, 05-400, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rafal Garlewicz

  Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: February 22, 2022
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)