Follow-Up of the Prevision® Hip Stem

Periprosthetic Fracture Around Prosthetic Joint Implant Clinical Trial

— PRESPECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833634
• Other study ID #: AAG-O-H-2008
• Status: Completed
• Start date: May 14, 2021
• Est. completion date: June 13, 2022

Study information

• Verified date: November 2022
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aseptic Loosening of Prosthetic Joint
• Periprosthetic Fracture Around Prosthetic Joint Implant
• Periprosthetic Fractures

Locations

Country	Name	City	State
Germany	Caritas-Krankenhaus Bad Mergentheim, Klinik für Orthopädie und Unfallchirurgie	Bad Mergentheim

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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