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Safety and Performance of PEEK Anchors in Extremities

Smith & Nephew logo

Smith & Nephew

Status

Completed

Conditions

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

Treatments

Device: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL

Study type

Observational

Funder types

Industry

Identifiers

NCT03782298
2018.15.SMD.PEEK.RET.EXT

Details and patient eligibility

About

Safety and performance of the study devices in extremities up to 12 months post-surgery

Enrollment

140 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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