The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured from polyether-ether-ketone (PEEK).
Male and female subjects 18 years of age or older.
Subjects with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis.
Subjects with a pre-operative Knee Society Score (KSS) Knee score of >25 and <75.
Subjects who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Subjects who have participated in a clinical study with an investigational product in the last 6 months.
Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio, neuropathic joints).
Single group
Total Knee Arthroplasty
DevicePrimary Total Knee Arthroplasty with a PEEK femoral component
Original Knee Society Score
The Knee Society Score rating system was first introduced during the late 1980's and has become the standard clinical evaluation system for reporting results for patients undergoing Total Knee Arthroplasty. Most major journals strongly encourage that total knee manuscripts include Knee Society Score rating scores as part of the result section. The Knee Society Score consists of points given for pain, range of motion, and stability. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices. The Knee Society Score is usually reported as the two scores, "Knee Score" and "Function Score," rather than a summation score. The KSS score has a maximum of 100 points for each domain (Knee and Function).
Knee Society Score (Knee Scores)
The Knee Society Score rating system was first introduced during the late 1980's and has become the standard clinical evaluation system for reporting results for patients undergoing Total Knee Arthroplasty. Most major journals strongly encourage that total knee manuscripts include Knee Society Score rating scores as part of the result section. The Knee Society Score consists of points given for pain, range of motion, and stability. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices. The Knee Society Score is usually reported as the two scores, "Knee Score" and "Function Score," rather than a summation score. The KSS score has a maximum of 100 points for each domain (Knee and Function).
Knee Society Score (Function Scores)
The Knee Society Score rating system was first introduced during the late 1980's and has become the standard clinical evaluation system for reporting results for patients undergoing Total Knee Arthroplasty. Most major journals strongly encourage that total knee manuscripts include Knee Society Score rating scores as part of the result section. The Knee Society Score consists of points given for pain, range of motion, and stability. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices. The Knee Society Score is usually reported as the two scores, "Knee Score" and "Function Score," rather than a summation score. The KSS score has a maximum of 100 points for each domain (Knee and Function).
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)
The KOOS-JR is self-administered and assesses three domains: stiffness (1 question), pain (4 questions), function / daily living (2 questions). The KOOS-JR meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. Each item (questions) is coded from 0 to 4. The raw responses are summed (0-28) which is then converted to an interval score based on the KOOS-JR conversion table. The score is a percentage score from 0 to 100, 0 representing total knee disability and 100 representing perfect knee health.
The Patient Reported Outcomes Measurement Information System (PROMIS) Global-10
The Patient Reported Outcomes Measurement Information System (PROMIS Global-10) is a valid and reliable patient assessment and consists of ten (10) items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life. The response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. The PROMIS 10 scores are predictive of healthcare utilization, mortality in general and disease-specific clinical populations.
Click on the lead sponsor to view all of their trials.
