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Periprosthetic Fracture Around Prosthetic Joint ImplantPRESPECTNCT04833634

Follow-Up of the Prevision® Hip Stem

An observational study of Periprosthetic Fracture Around Prosthetic Joint Implant and Aseptic Loosening of Prosthetic Joint, run by Aesculap AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
46 participants
Where
1 siteGermany
Study dates
14 May 2021to 13 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • All patients implanted with a Prevision® hip stem at the study site between 2014 and 2019
  • Written informed patient consent

Who cannot join

  • Patients < 18 years at surgery

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Bad Mergentheim, 97980

Other trials in Germany

About this study

Official title: 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.

Keywords
arthroplasty, replacement, hip, implant failure, failed primary hip arthroplasty, severe bone defects, complex bone fractures, septic loosening, poor bone remodeling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

Secondary outcomes (8)

  1. 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

    Measured: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

  2. 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".

    Measured: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

  3. Radiological evaluation (standard x-rays): Bone healing

    Union of the osteotomy

    • Healing of the fracture and of the greater trochanter, if applicable

    Measured: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

  4. Radiological evaluation (standard x-rays): osseointegration

    Distal and proximal radiographic bone ingrowth and Qualitative proximal remodeling

    Measured: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

  5. Radiological evaluation (standard x-rays): radiographic loosening

    Signs of radiographic loosening in the distal fixation zone

    Measured: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

  6. 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

    Measured: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

  7. 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.

    Measured: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

  8. 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

    Measured: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2021
  2. Study start14 May 2021
  3. Primary completion13 Jun 2022
  4. Study completion13 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04833634
Sponsor's protocol ID
AAG-O-H-2008
Acronym
PRESPECT
Status last verified
Nov 2022
First submitted
1 Apr 2021
Last updated
18 Nov 2022
Results posted
No
Data monitoring committee
No

Publications

  • Herold D, Kuttner A, Dreyer L, Eingartner C. Mid-term results of a cementless hip stem in femoral revision: how much diaphyseal press-fit do we need? Arch Orthop Trauma Surg. 2024 Apr;144(4):1813-1820. doi: 10.1007/s00402-023-05191-4. Epub 2024 Jan 13.

    PubMed 38217640

Questions about this trial

What is this clinical trial studying?

An observational study of Periprosthetic Fracture Around Prosthetic Joint Implant and Aseptic Loosening of Prosthetic Joint, run by Aesculap AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hip stem survival measured by Kaplan-Meier (time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04833634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.

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