Follow-Up of the Prevision® Hip Stem (PRESPECT)

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

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.

Study Overview

• Status: Completed
• Conditions: Periprosthetic Fracture Around Prosthetic Joint Implant; Aseptic Loosening of Prosthetic Joint

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Germany
  • Bad Mergentheim, Germany, 97980
    • Caritas-Krankenhaus Bad Mergentheim, Klinik für Orthopädie und Unfallchirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcome: Oxford Hip Score	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	One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Patient satisfaction with their endoprosthetic revision treatment	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".	One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Radiological evaluation (standard x-rays): Bone healing	Union of the osteotomy o Healing of the fracture and of the greater trochanter, if applicable	One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Radiological evaluation (standard x-rays): osseointegration	Distal and proximal radiographic bone ingrowth and Qualitative proximal remodeling	One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Radiological evaluation (standard x-rays): radiographic loosening	Signs of radiographic loosening in the distal fixation zone	One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Radiological evaluation (standard x-rays): stem subsidence	Stem subsidence from ap x-rays using landmarks of the femur (typically lesser trochanter) and of the prosthesis	One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Leg length difference	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.	One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Descriptive Analysis of (Serious) adverse events	(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	One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: implant failure; arthroplasty, replacement, hip; failed primary hip arthroplasty; severe bone defects; complex bone fractures; septic loosening; poor bone remodeling
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Periprosthetic Fractures
• Other Study ID Numbers: AAG-O-H-2008