Clinical trial NCT05007067: H-29 DELTA Multihole TT Study.
Official title: A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA Multihole TT Acetabular Cup.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis, Hip
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: Month 24
Secondary outcomes:
measure: ROM measurement
timeFrame: Pre-operative - Month 24
measure: VAS Pain
timeFrame: Pre-operative - Month 24
measure: Implant stability
timeFrame: Month 24
measure: Survival rate
timeFrame: Month 24
measure: Safety assessment
timeFrame: Intra-operative, Week 2, Week 6, Month 6, Month 12, Month 24
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
Study officials:
affiliation: Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
name: Rafal Garlewicz
role: PRINCIPAL_INVESTIGATOR
References: