H-28 DELTA ST-C and Minima Retrospective Study. | NCT05014113

Studies
H-28 DELTA ST-C and Minima Retrospective Study.

NCT05014113

Sponsor

Limacorporate S.p.a

Status

Unknown status

Last Update Posted

Aug 20, 2021Actual

Enrollment

95Estimated

Phase

Not provided

Conditions

Osteoarthritis, Hip

Interventions

DELTA-ST cup in combination with MINIMA stem

Countries

Greece

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Mar 31, 2022Estimated

Completion Date

Mar 31, 2022Estimated

First Submitted Date

Aug 9, 2021

First Submission Date that Met QC Criteria

Aug 19, 2021

First Posted Date

Aug 20, 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

Aug 19, 2021

Last Update Posted Date

Aug 20, 2021Actual

Name	Type	Description	Arm Group Labels	Other Names
DELTA-ST cup in combination with MINIMA stem	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)	Assessment of Harris Hip Score from pre-operative baseline up to 3 years after surgery	Pre-operative - Month 36

Secondary Outcomes

Measure	Description	Time Frame
Stability assessment of DELTA ST-C cup	Radiographic analysis and stability assessment of the DELTA ST-C cup as rate of symptomatic radiolucent lines, loosening, and subsidence ≥ 2 mm from discharge (baseline) up to 3-year follow-up	At discharge - Month 36
Stability assessment of MINIMA stem

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Underwent to a THA with DELTA ST-C cup and MINIMA stem in 2017 onwards
Both genders
Any race
A diagnosis in the target hip of one or more of the following:
1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis
2. Rheumatoid Arthritis
3. Post-traumatic arthritis
4. Fractures of femoral neck
5. Congenital or acquired deformity
Patient willingness to participate

Exclusion Criteria:

Local or systemic infection
Septicaemia
Persistent acute or chronic osteomyelitis
Confirmed nerve or muscle lesion compromising hip joint function
Vascular or nerve diseases affecting the concerned limb
Poor bone stock (for example due to osteoporosis) compromising the stability of the implant
Metabolic disorders which may impair fixation and stability of the implant
Any concomitant disease and dependence that might affect the implanted prosthesis
Metal hypersensitivity to implant materials
Required revision of previous standard femoral stem
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

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 95 consecutive patients who underwent to a THA with DELTA ST-C cup in combination with MINIMA stem in 2017 onwards at the Psychiko Clinic and are compliant with all the Inclusion and Exclusion criteria.

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Fabiana Pavan	Contact	+393485816391		fabiana.pavan@limacorporate.com
Federica Azzimonti	Contact	+393775450940		federica.azzimonti@limacorporate.com

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