Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548581
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
The SpeedPlate Rapid Compression Implant Study The SPRINT Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Radiographic and Patient Reported Outcomes Following Joint Arthrodesis Following the Use of the SpeedPlate Rapid Compression Implants An Ambidirectional Cohort Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPRINT
Brief Summary:
Post-market observational multicenter unblinded ambidirectional cohort study to evaluate outcomes of study participants treated with the SpeedPlate product
Up to 200 participants will be treated in this study at up to 15 clinical sites
Patients 14 years through 65 years that have had MTP andor TMT joint fixation with the SpeedPlate Rapid Compression Implants will be eligible to participate based on the inclusion and exclusion criteria defined in this protocol
Up to 200 participants will be treated in this study at up to 15 clinical sites
Patients 14 years through 65 years that have had MTP andor TMT joint fixation with the SpeedPlate Rapid Compression Implants will be eligible to participate based on the inclusion and exclusion criteria defined in this protocol
Detailed Description:
The objectives of this study are to evaluate
1 Healingunion rates following joint fixation using the SpeedPlate Rapid Compression Implants
2 Whether early weight-bearing WB following joint fixation using the SpeedPlate Rapid Compression Implants affects the healingunion rates
3 Quality of life pain scores and patient satisfaction following joint arthrodesis using the SpeedPlate Rapid Compression Implants
1 Healingunion rates following joint fixation using the SpeedPlate Rapid Compression Implants
2 Whether early weight-bearing WB following joint fixation using the SpeedPlate Rapid Compression Implants affects the healingunion rates
3 Quality of life pain scores and patient satisfaction following joint arthrodesis using the SpeedPlate Rapid Compression Implants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None