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

Completed

Conditions studied: Humerus Fractures

In brief

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.

Key facts

Study ID

NCT05143476

Run by

Major Extremity Trauma Research Consortium

People needed

45

Starts

2021-06-26

Expected to finish

2024-10-28

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Immunocompromised based on the medical record and patient reported use of pharmacological medications that would lead to immunocompromise. (i.e., Anti-TNF therapies, or associated therapies for treatment of various rheumatological conditions.)
• Unable to comply with postoperative rehabilitation protocols or instructions (i.e., head injury or cognitively impaired).
• Known metabolic bone disease.
• Severe problems with maintaining follow-up (e.g., patients who are prisoners or homeless at the time of injury or who are intellectually challenged without adequate family support).

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.