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

NCT ID: NCT05014113

Last Updated: 2021-08-20

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

UNKNOWN

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2022-03-31

Brief Summary

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The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant.

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-ST cup in combination with MINIMA stem

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Limacorporate S.p.a

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Psychiko Clinic (Athens Medical Group)

Athens, Psychiko, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Fabiana Pavan

Role: CONTACT

+393485816391

Federica Azzimonti

Role: CONTACT

+393775450940

Facility Contacts

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Angeliki Syrigou

Role: primary

Other Identifiers

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H-28

Identifier Type: -

Identifier Source: org_study_id

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