Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-07-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Total knee replacement (TKR) without Omnibot system
The participant will undergo TKR utilizing conventional techniques.
Conventional Total knee replacement
Conventional total knee replacement without robotic assistance
Total knee replacement (TKR) with Omnibot
The participant will undergo a robotic assisted TKR utilizing the Omnibot Knee System
Total knee replacement using Omnibot Knee System
total knee replacement with robotic assistance
Omnibot Robotic Knee System
utilizes an active motorized knee spacer to measure ligament tension and gap balance after the tibia has been cut during surgery
Interventions
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Total knee replacement using Omnibot Knee System
total knee replacement with robotic assistance
Conventional Total knee replacement
Conventional total knee replacement without robotic assistance
Omnibot Robotic Knee System
utilizes an active motorized knee spacer to measure ligament tension and gap balance after the tibia has been cut during surgery
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of primary osteoarthritis
Exclusion Criteria
* Bilateral knee surgery
* Age \<18 or \>80
* BMI \>40
* Baseline lower extremity strength less than 5/5
* History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
* Functionally limiting spine disease
* Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
* Patients who cannot perform the baseline functional tests
* Allergy/contraindication to protocol medications
* Post-traumatic arthritis
* Inflammatory arthritis
* Pregnancy
* Prisoners
* Patients receiving care as a result of a worker's compensable injury
* General anesthesia
18 Years
ALL
Yes
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Principal Investigators
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Matt Austin, MD
Role: PRINCIPAL_INVESTIGATOR
Rothman Orthopaedic Institute
Locations
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Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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MAUS 22D.103
Identifier Type: -
Identifier Source: org_study_id
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