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

• Sponsor: Smith & Nephew, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03782298
• Collaborator: (none)
• Enrollment: 122
• Locations: 5
• Actual Duration (Months): 5.1
• Patients Per Site: 24.4
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Medial 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	Device: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL

Study Design

• Study Type: Observational
• Actual Enrollment: 122 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptormite, Footprint Ultra PK SL) in Extremities
• Actual Study Start Date: Mar 12, 2019
• Actual Primary Completion Date: Aug 15, 2019
• Actual Study Completion Date: Aug 15, 2019

Outcome Measures

Primary Outcome Measures

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

   Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon.

Secondary Outcome Measures

1. Safety and performance of the study devices in extremities over a time period of 12 months after intervention [12 months]

   Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon

Other Outcome Measures

1. Visual Analog Scale (VAS) - pain [12 months]

   0 to 10 is the scoring range of pain for the joint that received treatment with the anchor

2. Range of Motion (ROM) [12 months]

   Shoulder-full functional arc, forward flexion angle, internal, external rotation will be captured in degrees.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OrthoCarolina	Charlotte	North Carolina	United States	28207
2	Precision Orthopaedic Specialties, Inc.	Chardon	Ohio	United States	44024
3	Foot and Ankle Associates of North Texas-Grapevine	Grapevine	Texas	United States	76051
4	Bear Creek Surgery Center	Keller	Texas	United States	76248
5	Fowler Kennedy Sport Medicine Clinic	London	Ontario	Canada	N6A 3K7

Sponsors and Collaborators

• Smith & Nephew, Inc.

Investigators

• Study Chair: Judth Horner, Smith & Nephew, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Smith & Nephew, Inc.
• ClinicalTrials.gov Identifier: NCT03782298
• Other Study ID Numbers: SMD.PEEK.RET.EXT
• First Posted: Dec 20, 2018
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Smith & Nephew, Inc.: Dynomite; Spyromite; Raptormite; Foot; Ankle; Wrist; Hand; Elbow
• Additional relevant MeSH terms: Tennis Elbow; Hallux Valgus

Study Results

No Results Posted as of Jun 17, 2020