Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptomite) in Extremities

Bunionectomy Clinical Trial

Official title:

Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptormite, Footprint Ultra PK SL) in Extremities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782298
• Other study ID #: SMD.PEEK.RET.EXT
• Status: Completed
• Start date: March 12, 2019
• Est. completion date: August 15, 2019

Study information

• Verified date: June 2020
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Safety and performance of the study devices in extremities over a time period of 6 months after intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects who have undergone extremity joint repair using the study devices.

• Subjects aged 18 years and older at the time of surgery.

Exclusion Criteria:

• Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

• Subjects who are < 3 months post-operative

Related Conditions & MeSH terms

• Achilles Tendon Repairs/Reconstructions
• Bicep Tendon Reattachments
• Bunionectomy
• Hallux Valgus
• Hallux Valgus Repairs
• Lateral Epicondylitis Repair
• Medial or Lateral Instability Repairs/Reconstructions
• Metatarsal Ligament/Tendon Repairs/Reconstructions
• Midfoot Reconstructions
• Scapholunate Ligament Reconstructions
• Tennis Elbow
• Ulnar

Intervention

Device:
• Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL
Observational, post-market, clinical follow-up study

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sport Medicine Clinic	London	Ontario
United States	Precision Orthopaedic Specialties, Inc.	Chardon	Ohio
United States	OrthoCarolina	Charlotte	North Carolina
United States	Foot and Ankle Associates of North Texas-Grapevine	Grapevine	Texas
United States	Bear Creek Surgery Center	Keller	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analog Scale (VAS) - pain	0 to 10 is the scoring range of pain for the joint that received treatment with the anchor	12 months
Other	Range of Motion (ROM)	Shoulder-full functional arc, forward flexion angle, internal, external rotation will be captured in degrees.	12 months
Primary	Safety and performance of the study devices in extremities over a time period of 6 months after intervention.	Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon.	6 months
Secondary	Safety and performance of the study devices in extremities over a time period of 12 months after intervention	Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon	12 months