Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The Mako-MORE Registry is a prospective, post-market, multi-center registry-based evaluation of the Mako Robotic-Arm Assisted System used in total hip arthroplasty (primary and revision), total knee arthroplasty, and partial knee arthroplasty. The registry includes both Mako-assisted and manual arthroplasty cohorts to support real-world data collection.
Eligible patients undergoing arthroplasty using cleared Mako SmartRobotics™ applications or manual procedures will be enrolled and followed according to standard-of-care clinical practice. Data collected include demographics, procedural details, patient-reported outcomes, health utility measures, radiographic imaging, and adverse event information. Follow-up assessments will occur from the preoperative period through five years postoperatively.
The primary purpose of the registry is observational and descriptive. No investigational devices or experimental interventions are used, and all procedures are performed in accordance with FDA-cleared labeling and institutional standards of care.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5.0 THA (Primary) | This cohort includes patients undergoing primary total hip arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (THA 5.0 application). |
| |
| 5.0 THA (Revision) | This cohort includes patients undergoing revision total hip arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (THA 5.0 application). |
| |
| 3.0 TKA (Primary) | This cohort includes patients undergoing primary total knee arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (TKA 3.0 application). |
| |
| 3.1 PKA (Primary) | This cohort includes patients undergoing primary partial knee arthroplasty using FDA-cleared Stryker implants with the Mako Robotic-Arm Assisted System (PKA 3.1 application). |
| |
| Manual THA (Primary) | This cohort includes patients undergoing primary total hip arthroplasty performed using manual surgical instrumentation, without robotic assistance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mako Robotic-Arm Assisted Arthroplasty | Device | This observational registry does not assign or mandate any intervention. Participants included in this group undergo hip or knee arthroplasty using the FDA-cleared Mako Robotic-Arm Assisted System as part of routine clinical care. Surgical approach, implant selection, and perioperative management are determined by the treating surgeon according to standard practice. Outcomes are observed prospectively without alteration to clinical care. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship at 2 Years Postoperative | To evaluate survival rate at 2-years postoperative for Stryker devices implanted with the Mako Robotic-Arm Assisted System. Survival is defined as the absence of revision for implanted devices. | 2-years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship at 5 Years Postoperative | To evaluate survival rate at 5-years postoperative for Stryker devices implanted with the Mako Robotic-Arm Assisted System. Survival is defined as the absence of revision for implanted devices. | 5-years postoperative |
| Change in Patient-Reported Outcomes From Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The subject population enrolled within the study is reflective of the anticipated real-world patients who would be appropriate candidates for treatment using Mako SmartRobotics™ applications and indications or manual surgery, depending on the relevant study cohorts
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yonandy Barrientos | Contact | 347-281-3196 | yonandy.barrientos@stryker.com | |
| Marissa M Puccio | Contact | 201-675-1416 | marissa.puccio@stryker.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic (Jacksonville) | Jacksonville | Florida | 32224 | United States |
Not provided
Not provided
Not provided
Not provided
| Manual TKA (Primary) | This cohort includes patients undergoing primary total knee arthroplasty performed using manual surgical instrumentation, without robotic assistance. |
|
|
To evaluate changes between preoperative and postoperative patient reported outcomes (PROs). |
| 5-years postoperative |
| UofL Health | Louisville | Kentucky | 40202 | United States |
|
| NYU Langone Orthopedic Hospital | New York | New York | 10003 | United States |
|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
|
| Ortho Rhode Island | Wakefield | Rhode Island | 02879 | United States |
|