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Sponsor: Stryker Orthopaedics
Conditions: Arthropathy of Knee, Arthropathy of Hip
Interventions: Mako Robotic-Arm Assisted Arthroplasty
Countries: United States
This is a prospective, post-market, multi-center, registry-based observational study designed to collect real-world clinical data on patients undergoing joint arthroplasty with Stryker implants, with or without the use of the Mako Robotic-Arm Assisted System. The registry will collect prospective data on patient characteristics, procedural details, patient-reported outcomes, radiographic assessments, and adverse events. Patients will be enrolled into procedure-specific cohorts and followed for up to five years postoperatively.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Inclusion Criteria: * The subject is skeletally mature, and ≥ 18 years old. * The Subject has signed and dated an IRB/EC approved, study specific Informed Patient Consent Form (ICF). * The subject is scheduled to undergo manual arthroplasty or Mako Robotic-Arm Assisted Arthroplasty according to IFU. * The subject is willing and able to comply with postoperative scheduled clinical evaluations. Exclusion Criteria: * The subject is not able to express his/her consent as deemed by the investigator. * The subject is not able to fulfill a self-assessment questionnaire or follow-up visits as deemed by the investigator. * The subject is a prisoner. * Per surgeon discretion the subject is not a candidate for the study. * The subject is pregnant or breastfeeding.
- Jacksonville, Florida, United States
- Louisville, Kentucky, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Wakefield, Rhode Island, United States