At a glance
ClinicalIndex Comparison RecordN/ACompleted· 140 enrolled
Drug / intervention
Spyromite, Dynomite, Raptomite, Footprint Ultra PK SLdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Performance of PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL) in Extremities
In Brief
An observational study evaluating Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL for Medial or Lateral Instability Repairs/Reconstructions and 9 related conditions. Completed, enrolled 140 participants across 4 sites in 2 countries.
Detailed Summary
Safety and performance of the study devices in extremities up to 12 months post-surgery
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMedial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Bunionectomy, Scapholunate Ligament Reconstructions, Ulnar, Lateral Epicondylitis Repair, Bicep Tendon Reattachments
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartMar 2019
Primary CompletionOct 2019
TodayJul 2026
First PostedDec 20, 2018
Enrollment StartMar 12, 2019
Primary CompletionOct 10, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.5 years ago
Interventions
Spyromite, Dynomite, Raptomite, Footprint Ultra PK SLdevice
PEEK Suture Anchors, which include: * SPYROMITE™ 2.0 PK Suture Anchor with Needles * DYNOMITE™ 2.0 PK Suture Anchor with Needles * RAPTORMITE™ 3.0 Suture Anchor with Needles * FOOTPRINT™ Ultra PK SL Suture Anchor