An observational study in Wounds and Injuries, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Cedars-Sinai Medical Center · Observational
The purpose of this study is to examine the impact of a medically tailored post-operative meal delivery program on surgical outcomes and metabolic lab markers in orthopaedic trauma patients. Patients will have 12 days of meals and shakes delivered to their house through our partnership with Meals on Wheels. Metabolic lab values will be drawn at the 2 week and 6 week post-op visits. All patients will be followed for up to 1 year postoperatively.
This project addresses critical gaps in our understanding of how malnutrition affects recovery in orthopaedic trauma patients by focusing on three key outcomes: (1) the incidence of acute wound complications, (2) metabolic biomarker changes over time, and (3) patient-reported outcomes (PROMIS scores) and impact (qualitative survey) during the recovery period. By systematically investigating these outcomes, the project aims to understand how post-operative meal supplementation can be optimized to reduce complications and improve recovery. The findings will have significant implications for clinical practice, particularly in developing nutritional programs and guidelines that can be integrated into post-operative care protocols to improve outcomes and reduce healthcare costs for orthopaedic trauma patients.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 75 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Orthopaedic trauma surgical patients that have had an operation and inpatient stay at Cedars-Sinai Medical Center
Exclusion Criteria:
Discharged home from hospital, skilled nursing facility, or acute rehab
Metabolic biomarker changes over time
Evaluation of biomarkers
Time frame: From enrollment to 6-weeks postop
Incidence of acute wound complications
Wound compliaction
Time frame: From enrollment to end of treatment at 1-year postop
Patient-reported outcomes Depression
The PROMIS Depression scale is a self-reported measure used to assess negative mood, views of self, and social cognition associated with depressive symptoms. Scores are reported on a T-score metric, standardized with a mean of 50 and standard deviation of 10, based on the U.S. general population. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate worse outcomes, meaning more severe depressive symptoms. A T-score of 50 represents the average level of depressive symptoms in the general population.
Time frame: From enrollment to end of study period at 1-year postop
Patient-reported outcomes Anxiety
The PROMIS Anxiety scale measures fear, anxious misery, hyperarousal, and somatic symptoms related to anxiety. Like other PROMIS instruments, it uses a T-score metric with a mean of 50 and standard deviation of 10. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate worse outcomes, meaning greater severity of anxiety symptoms. A T-score of 50 reflects the average level of anxiety symptoms in the general population.
Time frame: From enrollment to end of study period at 1-year postop
Patient-reported outcomes Physical Function
The PROMIS Physical Function scale evaluates an individual's capability to perform physical activities such as mobility, dexterity, and self-care. Scores are reported using a T-score, standardized with a mean of 50 and standard deviation of 10. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate better outcomes, meaning greater physical functioning. A T-score of 50 reflects the average physical function in the general population.
Time frame: From enrollment to end of study period at 1-year postop
Patient-reported outcomes Pain Interference
The PROMIS Pain Interference scale assesses the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It is scored on the T-score metric, with a mean of 50 and standard deviation of 10. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate worse outcomes, meaning pain is interfering more with daily life. A T-score of 50 indicates average pain interference relative to the general population.
Time frame: From enrollment to end of study period at 1-year postop
Plan to share: No
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Cedars-Sinai Medical Center