Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT00951951
Eligibility Criteria:
Inclusion Criteria:
* Patients fulfilling the standard criteria for the implantation of primary total hip arthroplasty
* Those presenting with primary or secondary osteoarthritis
* Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use)
Exclusion Criteria:
* Pregnant women or women who plan to conceive within the year following surgery
* Inflammatory arthritic condition
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
* Those already treated with a failed Total Hip Arthroplasty (THA)
* Muscle contracture around the hip joint
* Individuals who have undergone organ transplant
* Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
* Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
* Individuals who have had a THA on the contra-lateral side within the 6 months.
* Individuals who have undergone a THR on the contra-lateral side and whose outcome is considered unsatisfactory or not good
* Individuals requiring bilateral hip replacement
* Individuals whose body mass index (BMI; kg/m2) \>40
* Individuals with active or suspected infection or sepsis
* Individuals with chronic renal failure as defined by the need for dialysis
* Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV
* History of drug and/or substance abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00951951
Study Brief:
Protocol Section:
NCT00951951