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.
Study Type
OBSERVATIONAL
Enrollment
46
Caritas-Krankenhaus Bad Mergentheim, Klinik für Orthopädie und Unfallchirurgie
Bad Mergentheim, Germany
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.
Time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
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
Time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
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".
Time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Radiological evaluation (standard x-rays): Bone healing
Union of the osteotomy o Healing of the fracture and of the greater trochanter, if applicable
Time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Radiological evaluation (standard x-rays): osseointegration
Distal and proximal radiographic bone ingrowth and Qualitative proximal remodeling
Time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
Radiological evaluation (standard x-rays): radiographic loosening
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Signs of radiographic loosening in the distal fixation zone
Time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
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
Time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
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.
Time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation
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
Time frame: One scheduled Follow-Up visit per patient, 2-7 years after initial implantation