3Spine announced completion of the first series of U.S. surgeries in the BalancedBack Total Joint Replacement Investigational Device Exemption (IDE) pivotal clinical trial. All patients enrolled in the trial will receive the MOTUS device and will be propensity-matched against patients prospectively enrolled in 3Spine’s real-world evidence (RWE) fusion study, using an adaptive statistical design. 3Spine’s RWE study has been enrolling in the U.S. since May 2021.
Each patient treated in the IDE trial was up and walking within two hours post-op, using the early mobilization protocols for hip and knee arthroplasty patients.
3Spine’s MOTUS device, the implant used in the BalancedBack Total Joint Replacement procedure, is a “first of kind” technology designed to replace the function of the disc and facet joints through a posterior approach. The procedure is intended to broadly address leg pain, back pain and spinal instability, while correcting posture and restoring freedom of movement through reconstruction of the functional spinal unit.
3Spine is seeking single-level indications from L1-S1 in patients suffering from lumbar degeneration with or without foraminal or recess spinal stenosis with no more than a grade 1 spondylolisthesis at the involved level.
3Spine announced completion of the first series of U.S. surgeries in the BalancedBack Total Joint Replacement Investigational Device Exemption (IDE) pivotal clinical trial. All patients enrolled in the trial will receive the MOTUS device and will be propensity-matched against patients prospectively enrolled in 3Spine's real-world...
3Spine announced completion of the first series of U.S. surgeries in the BalancedBack Total Joint Replacement Investigational Device Exemption (IDE) pivotal clinical trial. All patients enrolled in the trial will receive the MOTUS device and will be propensity-matched against patients prospectively enrolled in 3Spine’s real-world evidence (RWE) fusion study, using an adaptive statistical design. 3Spine’s RWE study has been enrolling in the U.S. since May 2021.
Each patient treated in the IDE trial was up and walking within two hours post-op, using the early mobilization protocols for hip and knee arthroplasty patients.
3Spine’s MOTUS device, the implant used in the BalancedBack Total Joint Replacement procedure, is a “first of kind” technology designed to replace the function of the disc and facet joints through a posterior approach. The procedure is intended to broadly address leg pain, back pain and spinal instability, while correcting posture and restoring freedom of movement through reconstruction of the functional spinal unit.
3Spine is seeking single-level indications from L1-S1 in patients suffering from lumbar degeneration with or without foraminal or recess spinal stenosis with no more than a grade 1 spondylolisthesis at the involved level.
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