Polarstem Cementless Hip Stem
This trial is active, not recruiting.
|Sponsor||Smith & Nephew, Inc.|
|Start date||March 2009|
|End date||April 2021|
|Trial size||225 participants|
|Trial identifier||NCT02648152, D10070|
Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Bochum, Germany||St. Elisabeth Hospital, Orthopedics and Rheumatology||no longer recruiting|
|Marburg, Germany||University Marburg, Orthopedics and Rheumatology||no longer recruiting|
|Aarau, Switzerland||Kantonsspital Aarau, Orthopedics||no longer recruiting|
Long term survivorship of Polarstem
time frame: 10 years Follow Up after surgery
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: - Patient has no general medical contraindication to surgery - Informed consent to participate in the MCO signed by the patient - Routine radiographic assessment is possible - Patient is likely to comply with study follow-up requirements - Primary total hip replacement (THR) to the affected side, unilateral or bilateral Exclusion Criteria: - Previously failed endoprosthesis and /or THR components in relevant hip - History of infection in the affected joint; systemic infections - Grossly insufficient femoral or acetabular bone stock in the involved hip - Charcot joint disease or other severe neurosensory deficit - Severe spinal disorders - Age of patient at date of surgery > 75 years - High comorbidity - Cemented acetabular cup
|Official title||Multicenter Clinical Observation Using the Cementless Version of the POLARSTEM|
|Principal investigator||Turgay Efe, Dr.med.|
|Description||The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™. Efficacy evaluations: - Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) [7, 8], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). - Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration Safety evaluations: - Intra- and perioperative device-related adverse events (AE) and complications up to discharge - Postoperative AE up to 10 years|
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