Active — Not RecruitingNot Applicable

MDR - Biomet Cannulated Screws

United States51 participantsStarted 2019-08-07

Plain-language summary

The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
✓. Arthrodesis of the foot, wrist and elbow.
✓. Small and long bone osteotomies.
✓. Fracture fixation of small bones, small bone fragments and long bones.
✓. Fixation of fractures in long bones and long bone fragments.
✓. Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
✓. Arthrodesis and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
✓. Slipped capital femoral epiphysis

What they're measuring

Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events

Timeframe: Out to12+ months

Trial details

NCT IDNCT04002518

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Fractures, Bone trials