CompletedNot Applicable

Serum-Protein-Based Indices for the Progression of Fracture Healing and Nonunion

United States45 participantsStarted 2021-06-26

Plain-language summary

To define a serum protein-based diagnostic for the progression and failure of fracture healing, through the identification of a set of serum proteins that appear at early times of biological healing and show a specific correlation with later radiological and functional signs used to define delayed healing and non-union.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Skeletally mature, ages 18-70 (inclusive)
✓. Diagnosis of isolated closed extra-articular fractures of the humeral shaft deemed appropriate for closed treatment by immobilization and a sling by the treating physician
✓. Approached for consent within two weeks of injury
✓. Available for follow up at this treatment facility for at least six months

Exclusion criteria

✕. Humeral shaft fractures that extend into the articular surface.
✕. Pathologic fractures.
✕. Additional long bone injuries or fractures of upper or lower extremity that would compromise outcome assessments of single fracture protein levels.
✕. Previous retained hardware in humerus from other injuries.
✕. Soft tissue injury compromising selected treatment method.
✕. Any injury that involved a trauma activation with entry of more than two AIS codes.
✕. Fractures with vascular injury.
✕. Pregnant women, potentially pregnant, or lactating women

What they're measuring

Fracture Healing Outcomes and Functional Healing Outcomes

Timeframe: 7-9 week visit

Trial details

NCT IDNCT05143476

SponsorMajor Extremity Trauma Research Consortium

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-02

View on ClinicalTrials.gov More Humerus Fractures trials