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Completed

NCT Number: NCT04833634

Follow-Up of the Prevision® Hip Stem

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.

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Key information

Conditions

Periprosthetic Fracture Around Prosthetic Joint Implant Aseptic Loosening of Prosthetic Joint

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caritas-Krankenhaus Bad Mergentheim, Klinik für Orthopädie und Unfallchirurgie

Bad Mergentheim, 97980, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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".

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

Other outcomes

  1. Descriptive Analysis of Patient characteristics

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Acronym: PRESPECT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2021
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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