Follow-Up of the Prevision® Hip Stem

NCT04833634 | Completed

• 1 other identifier: AAG-O-H-2008
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hip stem survival measured by Kaplan-Meier

  The primary endpoint of the study is hip stem survival, which is a common indicator for implant performance, which can also be used for comparison with implant registry data.

  One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

Secondary Outcomes (8)

• Functional Outcome: Oxford Hip Score

  One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

• Patient satisfaction with their endoprosthetic revision treatment

  One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

• Radiological evaluation (standard x-rays): Bone healing

  One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

• Radiological evaluation (standard x-rays): osseointegration

  One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

• Radiological evaluation (standard x-rays): radiographic loosening

  One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

Other Outcomes (1)

• Descriptive Analysis of Patient characteristics

  One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients were implanted 2-7 year before the start of the retrospective study activities.

You may qualify if:

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

You may not qualify if:

• \- Patients \< 18 years at surgery

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (1)

Caritas-Krankenhaus Bad Mergentheim, Klinik für Orthopädie und Unfallchirurgie

Bad Mergentheim, 97980, Germany

Location

Related Publications (1)

• 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.

  PMID: 38217640 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 6, 2021
• Study Start: May 14, 2021
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

DE (1)