Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants

NCT06626490 | Recruiting

• 1 other identifier: AAG-O-H-23015
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem. The study is an observational post-market clinical follow-up study, and the study sites chose the stem variant depending on their own routine and indication.

Conditions

Revision Total Hip Arthroplasty; Periprosthetic Fracture of Hip

Keywords

Patient-reported outcomes; Clinical performance and safety; Total hip arthroplasty implantation

Outcome Measures

Primary Outcomes (1)

• Functional outcome of the hip revision surgery

  Oxford Hip Score:The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure designed to assess disability in patients undergoing total hip replacement (THR)

  after two years

Secondary Outcomes (7)

• Kaplan-Meier survival

  after two years

• EQ-5D-5L Quality of Life

  visits after 2 and 5 years

• Complications

  visits after 2 and 5 years

• Patient satisfaction

  visits after 2 and 5 years

• Pain (VAS Score)

  visits after 2 and 5 years

Interventions

Prevision Revision hip endoprosthesis stem implantation DEVICE

The Prevision hip endoprosthetic stem is a femoral part of a hip joint endoprosthesis. The system provides cementless and cemented variants. Prevision hip stems are modular with a short proximal and longer distal component, or monobloc hip stems. Modular components are coupled via a Prevision specific conical connection with a torque wrench and a tension nut to apply a predefined torsional moment on the connection. The distal component of modular Prevision stems can be combined with locking screws for additional bone fixation. Both types, the monobloc and the modular, provide a 12/14 taper that serves as a connection for metal or ceramic prosthesis heads. Prevision hip stems are combined at the acetabulum with a cementless or cemented acetabular cup.

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

Patients with indication of a hip revision

You may qualify if:

• Revision hip arthroplasty patients treated with a Prevision hip stem
• Written patient informed consent
• Patients are able to attend at follow-up examinations

You may not qualify if:

• Patients \< 18 years at surgery
• Pregnancy at implantation
• Patients held in a custodial setting
• Patients in a relationship of dependence on the sponsor, the clinic or the investigator

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (2)

Orthopädische Kliniken im Annastift, MHH, Anna-von-Borries-Str. 1-7

Hanover, 30625, Germany

RECRUITING

Hinchingbrooke Hospital

Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom

RECRUITING

Study Officials

• Henning Windhagen, Prof. Dr.

  Orthopädische Kliniken im Annastift, MHH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerstin Bergmann

CONTACT

+49746195-; studies@aesculap.de

Lutz Dreyer, Dr.

CONTACT

+49746195-; studies@aesculap.de

Study Design

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

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 3, 2024
• Study Start: April 7, 2026
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2034
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

GB (1); DE (1)