PRESPECT: Follow-Up of the Prevision® Hip Stem

Sponsor

Aesculap AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04833634

Collaborator

(none)

Enrollment

Location

18.6

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periprosthetic Fracture Around Prosthetic Joint Implant Aseptic Loosening of Prosthetic Joint

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Retrospective Follow-Up of the Prevision® Hip Stem in a Consecutive Case Series

Actual Study Start Date :

May 14, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Hip stem survival measured by Kaplan-Meier [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 Outcome Measures

Functional Outcome: Oxford Hip Score [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 [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 [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 [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 [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 [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 [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 [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

Other Outcome Measures

Descriptive Analysis of Patient characteristics [One scheduled Follow-Up visit per patient, 2-7 years after initial implantation]
Age, weight, gender, date of surgery, indication for revision, comorbidities, intraoperative details