- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06768541
Subsidence of Short Stem THA With DORR Type C
Short Stem Total Hip Arthroplasty in Patients With DORR Type C Femur Configuration: Measured Subsidence
Study Overview
Status
Intervention / Treatment
Detailed Description
In hip arthroplasty, short stems represent a key advancement in the field of bone-preserving surgical techniques. Due to the relatively rapid establishment of short stems, the data situation is lagging behind in some areas, resulting in uncertainties in the indication in certain cases. One of these cases is proximal femurs with a Dorr type C configuration. This bone characteristic complicates the implantation of stems due to a thin cortical bone and a wide femoral canal and has been shown to lead to an increased complication rate. The aim of this study is to evaluate the clinical and radiological outcome of short stem implantation in Dorr type C femur. The study will include all patients who underwent implantation of the "Optimys" short stem from Mathys between January 1, 2018 and December 31, 2020 at the hospital Ordensklinikum Linz Barmherzige Schwestern. In addition, patients must have a type C femur according to Dorr. During a follow-up period of at least two years, the Harris Hip Score, the UCLA Activity-level Scale and the Singh Index are used to evaluate the clinical course. Radiological evaluation is carried out using pre- and postoperative X-rays, which together enable an EBRA-FCA.
A statement on the migration behavior of the cementless implanted short stem in Dorr type C femur is expected. To date, it has been controversially discussed whether a Dorr type C femur provides enough structural support to achieve good primary stability for a cementless implanted short stem with tapered-wedge design. If this were not the case, the excessive migration behavior would lead to subsidence and subsequently to aseptic stem loosening and even complete failure of the prosthesis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Linz, Austria, 4010
- Ordensklinikum Linz Barmherzige Schwestern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- THA using Optimys short stem from 1.1.2018 bis 31.12.2020 in the institution.
- Typ C Femur according to Dorr
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Dorr C Hip
Patients who received short stem THA with a Dorr C configuration of the femur
|
Total Hip Arthroplasty using a collarless, triple-tapered cementless short stem (Optimys, produced by Mathys).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stem Subsidence
Time Frame: 2 years
|
Subsidence of the femoral stem, measured in mm
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HHS
Time Frame: 2 years
|
Harris Hip Score, 0-100 points.
0 points indicate worst, 100 points indicate best outcome.
|
2 years
|
|
OHS
Time Frame: 2 years
|
Oxford Hip Score, 0-48points 0 points indicate worst, 48 points indicate best outcome.
|
2 years
|
|
SF-12
Time Frame: 2 years
|
Short Form 12, 12 questions with 0-100 points.
0 points indicate worst, 100 points indicate best outcome.
Norm-Based-Scoring is used.
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK1330/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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