Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty
WithdrawnNot applicableNCT05461638
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and radiographic analyses.
Study details
- Official title
- A Prospective, Randomized, Single-Blinded, Multi-Center, Clinical Trial Comparing Kinematic Alignment vs. Mechanical Alignment Using Medially-Stabilized Knee (GMK Sphere) And Patient-Specific Cutting Guides (MyKnee) For Total Knee Arthroplasty
- Conditions
- Interventions
- Procedure: Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides
- Procedure: Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides
- Sponsor
- Medacta USA
- Start date
- 2020-01-05
- Primary completion
- 2022-04-05
- Sex
- All
- Age range
- from 21 Years to 80 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF). * Ability to understand and provide written authorization for use and disclosure of personal health information. * Subject who are able and willing to comply with the study protocol and follow-up visits. * Must be 21 years or older to participate, and less than 80 years old. * Subjects must have osteoarthritis knee disease in the affected knee compliant with the FDA-approved indications for use of GMK Sphere knee system and MyKnee cutting blocks. * Patients who are candidates for Total Knee Arthroplasty and are determined to undergo a TKA using the Medacta GMK Sphere implant and MyKnee cutting blocks will be offered enrollment. * Subjects must be able to return for the follow-up appointments, and have the mental capacity to cooperate and complete PRO questionnaires, physical exam and radiographs. Exclusion Criteria: * • Cases of extreme bone loss requiring an augmented femoral or tibial implant and chronic ligamentous laxity requiring a constrained implant * The patient has a fixed flexion deformity of ≥15° * The patient has less than 90° of flexion * Patient is morbidly obese (BMI ≥40) * Patient with inflammatory arthritis * History of prior deep knee infection * History of alcoholism or drug abuse * Currently on chemotherapy or radiation therapy for neoplastic disease * Patient currently on immunosuppressive medications including steroids except when, (a) steroid use is less than 10mg daily, (b) other immunosuppressive medications are held for appropriate time, for example Adalimumab is held 2 weeks prior and 2 weeks after surgery * History of known sensitivity or allergy to materials used in orthopedic implants, specifically Titanium and Cobalt-Chrome alloys * Habitual use of narcotic pain medications prior to surgery (more than 2 doses daily and chronic use of a minimum 3 months) * History of metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis (e.g., Osteomalacia, Ricketts) * History of chronic pain issues for reasons other than knee joint pain. If the type of pain affects activities of daily living, do not enroll. If the pain is intermittent and does not affect activities of daily living, it is OK to enroll. Fibromyalgia is exclusionary. * Women who are pregnant * Patient with unstable psychiatric illness or psychosis is excluded. (Patients with …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05461638