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

NCT05143476 | Completed

• 1 other identifier: W81XWH-19-1-0796
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Humerus Fractures

Keywords

Limb Fractures; Failure to Progress; Nonunion; Serum Markers

Outcome Measures

Primary Outcomes (1)

• Fracture Healing Outcomes and Functional Healing Outcomes

  The primary outcome for the assessment of fracture healing will be assessed by gross motion and mRUST (modified radiograph union score) score greater than or equal to 6. mRUST score ranges from 4-16 where score greater than or equal to 6 is considered as the predictors of progression to union.

  7-9 week visit

Study Arms (1)

Observational group

Follow-up visits will be conducted at 4-6, 7-9, 12-16 and 26-32 weeks, from time of fracture. A participant's doctor will perform routine examination of fracture healing. The assessment will include evaluation of gross fracture site motion and presence or absence of radiographic healing, including a mRUST score.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will consent and enroll up to 180 patients who meet the enrollment inclusion exclusion criteria for this study. In this group we anticipate based on our prior clinical data that about 20 patients would experience failed healing (nonunion) providing us with the ability to identify those protein in the serum that are diagnostic for failed healing. Patient enrollment will take place continuously over a three year period with the two stages of the project initiated when the enrollment numbers are met to carry out each aim of the project. When a patient presents with a humerus fracture he or she will be evaluated (according to standard of care) for possible enrollment in the study. The inclusion /exclusion criteria will be reviewed by the treating surgeon.

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).

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead
• United States Department of Defense: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Each 50mL specimen will be divided into 40 mL of whole blood which will be fixed for storage and 10 mL which will be collected for plasma processing. Plasma samples will be used for analysis of up to \~2000 proteins found in plasma circulation in the blood during the learning phase (Aim1). During the validation phase (Aim2) a more restricted target group of 170 proteins will be assayed. The networks of interaction among various multiple inflammatory mediators, systemic response factors to trauma and locally produced proteins at the repair site during callus formation that spill into the serum will be analyzed. Whole blood as fixed for long term storage will be processed per study operating procedures, for future research endeavors directed at total blood immune cell profiling.

MeSH Terms

Conditions

Humeral Fractures; Dystocia

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Louis Gerstenfeld, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

• Renan C Castillo, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 3, 2021
• Study Start: June 26, 2021
• Primary Completion: May 2, 2024
• Study Completion: October 28, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)