Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem (NCT02471703) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem
Stopped: The study was prematurely terminated by S+N due to business reasons. After an extensive review of all ongoing studies with the focus on which studies are still required for regulatory obligations S+N took the decision to close the SMF S\&E study.
This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient presents with non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis of or any of it's composite diagnosis.
* Patient is of legal age to consent, is skeletally mature and at least 18 years old.
* Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
* Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.
Exclusion Criteria:
* Patient has poor bone stock and would make the procedure unjustifiable: A) patients which are under medical care for osteoporosis (taking hormones, Calcitonin or biphosphates) or for other metabolic pathologies, which could influence the quality of the bone (for example hyperparathyroidism, hyperthyreoidismus and osteomalacie) will be excluded from the study. B) patients suffering from Morbus Paget (osteodystrophia deformans) will be excluded from the study.
* Patient has conditions that tend to place increased loads on implants such as weight, chargot joint, muscular deficiencies and activity level, which are incompatible with a satisfactory long-term result: A) patients with a BMI \> 40 will be excluded from the study B) patients participating in high-impact sports like baseball, basketball, football, handball, hockey, karate, racquet-ball, running, soccer, water skiing or sim…