MagnetOs Putty Compared to Trinity Evolution in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion (PRECISE)
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|ClinicalTrials.gov Identifier: NCT05037968|
Recruitment Status : Not yet recruiting
First Posted : September 8, 2021
Last Update Posted : February 9, 2022
This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery.
In this study, MagnetOs Putty will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.
Trinity Evolution will also be used according to its latest IFU approved in the US. Specifically, Trinity Evolution is an allograft intended for the treatment of musculoskeletal defects.
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease Spine Fusion Leg Pain and/or Back Pain||Device: MagnetOs Putty||Not Applicable|
In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to four-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Putty on the assigned side of the spine and Trinity Evolution on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 4, Month 6, and Month 12. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Putty will be used as a bone graft extender mixed with autograft in a 1:1 vol% in patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Week 6, Month 4, Month 6 and Month 12. CT-scans will only be obtained at Month 6 and Month 12.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment, Intra-patient control. Each patient serves as their own control.|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Single-center Study to Assess the Performance of MagnEtOsTM Putty Compared to Trinity EvolutionTM in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)|
|Estimated Study Start Date :||April 2022|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: MagnetOs Putty
MagnetOs Putty use in instrumented posterolateral fusion, 7cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side
Device: MagnetOs Putty
Procedure: Instrumented Posterolateral Lumbar Fusion
Active Comparator: Trinity Evolution
Trinity Evolution is a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side.
Device: MagnetOs Putty
Procedure: Instrumented Posterolateral Lumbar Fusion
- Radiographic Fusion by CT Scan [ Time Frame: Month 12 ]The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
- Radiographic Fusion by Plain Radiographs [ Time Frame: Week 2, Week 6, Month 3 ]The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
- Radiographic Fusion by CT Scan [ Time Frame: Month 6 ]The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 6. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
- Functional Outcome by Oswestry Disability Index [ Time Frame: Week 2, Week 6, Month 3, Month 6, Month 12 ]Functional outcome by the Oswestry Disability Index questionnaire. Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability.
- Back and Leg Pain by Visual Analog Pain Scale (VAS) [ Time Frame: Week 2, Week 6, Month 3, Month 6, and Month 12 ]Change in back and leg pain using Visual Analog Pain Scale score. The patient completed questionnaire is a unidimensional measure of pain intensity using a continuous scale comprised of a horizontal line 10 centimeters (100 mm) in length. The line is anchored by "no pain" (score of 0) and "worst imaginable pain". A higher score indicates greater pain intensity.
- Neurologic Status by Physical Exam [ Time Frame: Week 2, Week 6, Month 3, Month 6, and Month 12 ]Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for lower extremities, specifically reflexes, muscle strength, sensory, and straight leg raise.
- Success Rate [ Time Frame: Week 2, Week 6, Month 3, Month 6, and Month12 ]Number of patients with secondary surgical interventions (SSI's) such as revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or removes part of the original implant configuration with or without replacement of the components within 12 months of surgery.
- Safety Endpoint - number of patients with Adverse Events [ Time Frame: 12 Months ]The number of patients with Adverse Events from Screening up to Month 12 after surgery.
- Safety Endpoint - number of patients with Serious Adverse Events [ Time Frame: 12 Months ]The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery
- Safety Endpoint - number of patients with Adverse Device Effects [ Time Frame: 12 Months ]The number of patients with Adverse Device Effects from Screening up to Month 12 after surgery.
- Safety Endpoint - number of patients with Device Related Complications [ Time Frame: 12 Months ]The number of patients with any complications considered to device related with 12 months after surgery.
- Health Economic - Duration of Surgery [ Time Frame: 12 Months ]Duration of surgery in minutes.
- Health Economic - Duration of Hospitalization [ Time Frame: 12 Months ]Duration of hospital stay in days.
- Health Economic - Return to Work [ Time Frame: 12 Months ]Time to return to work in days.
- Health Economic - Quality of Life [ Time Frame: 12 Months ]Change in Quality of Life measurement using EuroQol-5D/5L scoring
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): NCT05037968
|Contact: Pascal Longlade, MDfirstname.lastname@example.org|
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