Follow-Up of the Prevision® Hip Stem

NCT ID: NCT04833634

Last Updated: 2022-11-18

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

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-14

Study Completion Date

2022-06-13

Brief Summary

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The main objective of this study is to represent the treatment reality at the study site and to draw conclusions from cases of failure or suboptimal outcome. Potential risk factors for revision surgery, suboptimal outcome or radiologic sign of loosening, bone non-union or stem subsidence will be evaluated. Next to the functional outcome, stem subsidence will be used as an important indicator for a stable fixation of the revision stem.

Detailed Description

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Conditions

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Periprosthetic Fracture Around Prosthetic Joint Implant Aseptic Loosening of Prosthetic Joint

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All patients implanted with a Prevision® hip stem at the study site between 2014 and 2019
* Written informed patient consent

Exclusion Criteria

\- Patients \< 18 years at surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caritas-Krankenhaus Bad Mergentheim, Klinik für Orthopädie und Unfallchirurgie

Bad Mergentheim, , Germany

Site Status

Countries

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Germany

References

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Herold D, Kuttner A, Dreyer L, Eingartner C. Mid-term results of a cementless hip stem in femoral revision: how much diaphyseal press-fit do we need? Arch Orthop Trauma Surg. 2024 Apr;144(4):1813-1820. doi: 10.1007/s00402-023-05191-4. Epub 2024 Jan 13.

Reference Type DERIVED
PMID: 38217640 (View on PubMed)

Other Identifiers

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AAG-O-H-2008

Identifier Type: -

Identifier Source: org_study_id

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