H-29 DELTA Multihole TT Study.

Limacorporate

Status: Terminated

Conditions: Osteoarthritis, Hip

Treatments: Device: DELTA Multihole TT

Study type: Observational

Funder types: Industry

Identifiers

NCT05007067

H-29

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.