Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
Study Type
OBSERVATIONAL
Enrollment
294
Observational, post-market, clinical follow-up study
The Orthopaedic Center- Center for Advanced Orthopaedics
Washington D.C., District of Columbia, United States
Northshore University Health System
Chicago, Illinois, United States
Tulane University Medical Center /Tulane Institute of Sport Medicine
New Orleans, Louisiana, United States
Oklahoma Sports and Orthopedics Institute
Oklahoma City, Oklahoma, United States
Palmetto Health USC Orthopedic Center
Columbia, South Carolina, United States
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon
All individuals for whom the outcome of re-intervention is known at 6 months
Time frame: 6 months
Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon
All individuals for whom the outcome of re-intervention is known at 12 months
Time frame: 12 months
Hip Visual Analog Scale (VAS) - Pain
VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.
Time frame: Screening, 6 months, and 12 months
Knee Visual Analog Scale (VAS) - Pain
VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.
Time frame: Screening, 6 months, and 12 months
Shoulder Visual Analog Scale (VAS) - Pain
VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain.
Time frame: Screening, 6 months, and 12 months
Hip Range of Motion (ROM)
Full Range of Motion (ROM) defined as full functional arc in hip by the physician.
Time frame: Screening, 6 months, and 12 months
Knee Range of Motion (ROM)
Full Range of Motion (ROM) defined as full functional arc in knee by the physician
Time frame: Screening, 6 months, and 12 months
Shoulder Range of Motion (ROM)
Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician.
Time frame: Screening, 6 months, and 12 months
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