H-29 DELTA Multihole TT Study. | NCT05007067

Studies
H-29 DELTA Multihole TT Study.

NCT05007067

Sponsor

Limacorporate S.p.a

Status

Terminated

Last Update Posted

Feb 24, 2025Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Osteoarthritis, Hip

Interventions

DELTA Multihole TT

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of progress in fulfilling the Study activities, including the lack of enrollment of participants

Expanded Access Info

Start Date

Feb 22, 2022Actual

Primary Completion Date

Sep 26, 2024Actual

Completion Date

Sep 26, 2024Actual

First Submitted Date

Aug 9, 2021

First Submission Date that Met QC Criteria

Aug 9, 2021

First Posted Date

Aug 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2025

Last Update Posted Date

Feb 24, 2025Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases