H-29 DELTA Multihole TT Study.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-22

Study Completion Date

2024-09-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Hip

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No