Follow-Up of the Prevision® Hip Stem

Overview

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.

Full Title of Study: “Retrospective Follow-Up of the Prevision® Hip Stem in a Consecutive Case Series”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 2022

Clinical Trial Outcome Measures

Primary Measures

  • Hip stem survival measured by Kaplan-Meier
    • Time Frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
    • 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.

Secondary Measures

  • Functional Outcome: Oxford Hip Score
    • Time Frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
    • The Oxford Hip Score is a 12-item questionnaire that assesses hip function and pain. The score ranges between 12 and 60, with a lower score indicating less disability
  • Patient satisfaction with their endoprosthetic revision treatment
    • Time Frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
    • The Patients are asked to grade their level of satisfaction with the outcome of the surgery at time of follow-up, with the grades: “very dissatisfied”, “dissatisfied”, “satisfied”, “very satisfied”. The grades may be summarized as “satisfied” vs. “dissatisfied”.
  • Radiological evaluation (standard x-rays): Bone healing
    • Time Frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
    • Union of the osteotomy o Healing of the fracture and of the greater trochanter, if applicable
  • Radiological evaluation (standard x-rays): osseointegration
    • Time Frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
    • Distal and proximal radiographic bone ingrowth and Qualitative proximal remodeling
  • Radiological evaluation (standard x-rays): radiographic loosening
    • Time Frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
    • Signs of radiographic loosening in the distal fixation zone
  • Radiological evaluation (standard x-rays): stem subsidence
    • Time Frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
    • Stem subsidence from ap x-rays using landmarks of the femur (typically lesser trochanter) and of the prosthesis
  • Leg length difference
    • Time Frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
    • Discrepancy of leg length is often considered to be a problem after total hip replacement and can adversely affect an otherwise excellent outcome and may be associated with patient dissatisfaction.
  • Descriptive Analysis of (Serious) adverse events
    • Time Frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
    • (Serious) adverse events that are potentially related to the Total hip arthroplasty (THA) procedure or the THA implants will be recorded. These are events as reported by the patient, observed in the follow-up examinations or taken from the patient record

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aesculap AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Lutz Dreyer, Dr., +49-7461-95, lutz.dreyer@aesculap.de

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