WithdrawnNot Applicable

Observational Patient Registry of the Dynamic Locking Screws

Stopped: Due to the voluntary recall of the study device (DLS 3.7mm and DLS 5.0mm)

Australia0Started 2015-05

Plain-language summary

The purpose of this multi-center patient registry is to obtain first clinical results and to assess short and mid-term clinical outcome data of patients treated with DLS.

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: * Age: ≥18 years * Any of the following fracture types: * Proximal or diaphyseal humerus fracture * Diaphyseal or distal femur fracture * Diaphyseal, distal or proximal tibia fracture * Eligible for treatment with Synthes DLS and locked plate constructs (small or large fragments) * Patients able and willing to sign informed consent form * Patients able and willing to adhere to 12-months follow-up visits Exclusion Criteria: * Polytrauma * Pregnant or nursing females * Patients already participating in an investigational trial * Patients who are not expected to survive the follow-up period

What they're measuring

Radiographic callus formation and location of callus evaluation: Change over time

Timeframe: 6 weeks, 12 weeks, 6 months, and (12)* months

Trial details

NCT IDNCT02656628

SponsorSynthes GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-11

View on ClinicalTrials.gov More Proximal or Diaphyseal Humerus Fracture trials