Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
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ClinicalTrials.gov Identifier: NCT03106558 |
Recruitment Status : Unknown
Verified February 2017 by Rothman Institute Orthopaedics.
Recruitment status was: Enrolling by invitation
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Device: Total Knee Arthroplasty using Manual Instrumentation Device: Total Knee Arthroplasty using Robotic Arm | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty |
Actual Study Start Date : | June 2016 |
Estimated Primary Completion Date : | June 2019 |
Estimated Study Completion Date : | June 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Manual instrument total knee replacement |
Device: Total Knee Arthroplasty using Manual Instrumentation |
Active Comparator: Robitic arm total knee replacement |
Device: Total Knee Arthroplasty using Robotic Arm |
- Component alignment [ Time Frame: 6 weeks post knee arthroplasty ]CT scan measurement

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient requires primary total knee surgery
- Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
- Patient is willing to sign an IRB approved informed consent
- Patient is at least 18 years of age
Exclusion Criteria:
- Patient has a BMI > 50
- Patient is skeletally immature
- Patient has an active infection or suspected infection in or about the joint
- Bone stock that is inadequate to support fixation of the prosthesis
- Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
- Patients with mental or neurological conditions which may be incapable of following instructions.
- Blood supply limitations
- Collateral ligament insufficiency.
- Patients with prior HTOs or Unis.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106558
United States, Georgia | |
Athens Orthopedic Clinic | |
Athens, Georgia, United States, 30606 | |
United States, New Jersey | |
Rothman Institute | |
Egg Harbor Township, New Jersey, United States, 08234 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT03106558 |
Other Study ID Numbers: |
2017WHoz |
First Posted: | April 10, 2017 Key Record Dates |
Last Update Posted: | April 10, 2017 |
Last Verified: | February 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Osteoarthritis, Knee Osteoarthritis Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |