DELTA Multihole TT Study

NCT ID: NCT04375345

Last Updated: 2020-05-05

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-23

Study Completion Date

2022-03-23

Brief Summary

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A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.

Detailed Description

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Conditions

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Hip Osteoarthritis Arthroplasty Complications Hip Dysplasia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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hip arthroplasty

complex primary total hip arthroplasty or revision total hip arthroplasty performed through anterolateral or posterolateral approach

Intervention Type DEVICE

Other Intervention Names

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revision hip arthroplasty

Eligibility Criteria

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Inclusion Criteria

Age ≥ 18 years

* Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis;
* Signed Informed consent
* Hip dislocation using protruded liners, spacers;
* Rheumatoid arthritis;
* Post-traumatic arthritis;
* Correction of functional deformity in case of acetabulum verticalization, anteversion, and retroversion;
* Fractures of femoral neck;

If used in combination with spacers and hemispheric modules, other indications are:

* Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure;
* Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results;
* Where bone stock is of poor quality or is inadequate for other reconstruction techniques as indicated by deficiencies of the acetabulum.

Exclusion Criteria

* Local or systemic infections;
* 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 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.


• Female patients who are pregnant, nursing, or planning a pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Bratislava

OTHER

Sponsor Role lead

Responsible Party

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Boris Steno

Boris Steno MD PhD Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boris Steno, MD PhD Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bratislava

Locations

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2nd University Department of Orthopaedic and Trauma Surgery Comenius University Faculty of Medicine

Bratislava, , Slovakia

Site Status RECRUITING

Countries

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Slovakia

Central Contacts

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Boris Steno, MD PhD Prof

Role: CONTACT

+421905512004

Ilja Chandoga, MD PhD

Role: CONTACT

+421911643354

Other Identifiers

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UHBratislava

Identifier Type: -

Identifier Source: org_study_id

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