Clinical trial NCT04833634: Follow-Up of the Prevision® Hip Stem
Official title: Retrospective Follow-Up of the Prevision® Hip Stem in a Consecutive Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periprosthetic Fracture Around Prosthetic Joint Implant
Aseptic Loosening of Prosthetic Joint
Keywords: arthroplasty, replacement, hip
implant failure
failed primary hip arthroplasty
severe bone defects
complex bone fractures
septic loosening
poor bone remodeling
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2021-04-06
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients were implanted 2-7 year before the start of the retrospective study activities.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hip stem survival measured by Kaplan-Meier
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Secondary outcomes:
measure: Functional Outcome: Oxford Hip Score
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
measure: Patient satisfaction with their endoprosthetic revision treatment
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
measure: Radiological evaluation (standard x-rays): Bone healing
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
measure: Radiological evaluation (standard x-rays): osseointegration
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
measure: Radiological evaluation (standard x-rays): radiographic loosening
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
measure: Radiological evaluation (standard x-rays): stem subsidence
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
measure: Leg length difference
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
measure: Descriptive Analysis of (Serious) adverse events
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Other outcomes:
measure: Descriptive Analysis of Patient characteristics
timeFrame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Locations:
city: Bad Mergentheim
country: Germany
facility: Caritas-Krankenhaus Bad Mergentheim, Klinik für Orthopädie und Unfallchirurgie
Study officials:
References: