Primary and secondary hip osteoarthritis and femoral head necrosis (ICD-10-GM: M16.0-9, M87.05, M87.15, M87.25, M87.35, M87.85, M87.95)
Conditions
Interventions
Group 1: At the Orthopedic Clinic of the University of Regensburg in Bad Abbach, depending on the femoral anatomy, either the metaphyseally anchored ACTIS stem, which can be implanted via an anterolat
Sponsors
Klinik für Orthopädie, Universität Regensburg, Asklepios Klinik Bad Abbach
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The study includes patients who, due to primary or secondary hip osteoarthritis or femoral head necrosis, have undergone cementless total hip arthroplasty/replacement with Type ACTIS or Corail at the Department of Orthopaedics at the University of Regensburg in the Asklepios Clinic in Bad Abbach, since the ACTIS stem was first implanted at this clinic. Period: Due to the retrospective study design, with a follow-up of at least 12 months and a study start date of February 2026, the analysed period for surgical intervention is from September 27, 2021, to January 31, 2025.
Exclusion criteria
Exclusion criteria: Patients who are unable to give consent (e.g., under 18 years of age, language barrier, under legal guardianship, etc.) are excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study are demographic characteristics of patients who have undergone total hip arthroplasty (THA)/total hip replacement (THR) using ACTIS or Corail stems, as well as data on the immediate intra- and postoperative phase and long-term course, which are collected during the recommended follow-up examinations in our consultation hours. These include: - Age at the time of implantation - Gender - Height - Weight - BMI - Length of hospital stay - Surgery time - Complications, e.g., need for a transfusion In addition, the pre- and postoperative X-ray images already available are compared and analyzed with regard to: - Canal flare index (Dorr classification) - Lap formation/radiolucency - Post-sintering - Cortical hypertrophy - Bone quality (if DEXA available) The respective measurement time is determined individually based on the respective routine follow-up appointments of the patients during consultation hours as part of the regular follow-up check-up after surgery. There are no study-related follow-up appointments. A follow-up period of at least 12 months is required. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary endpoints, PROMs are analyzed to reflect the clinical and functional outcomes of the intervention. The PROMs are collected pre- and postoperatively using various questionnaires as part of the regular surgical preparation and follow-up treatment. These include both joint-specific PROMs and general PROMs, such as: - HOOS Score - EuroQol 5D-5L - WOMAC Osteoarthritis Index - Forgotten Joint Score (FJS) - UCLA Score | — |
Countries
Germany
Contacts
Public ContactFabian Westhauser
Klinik für Orthopädie, Universität Regensburg, Asklepios Klinik Bad Abbach
Outcome results
None listed