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Spine and Tumor Screening and Supplementation

Improving Preoperative Screening and Postoperative Nutrition in Orthopedic Sarcoma and Spine Patients: Pilot Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03660540
Enrollment
0
Registered
2018-09-06
Start date
2021-01-31
Completion date
2021-05-01
Last updated
2023-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Deficiency, Sarcoma, Spinal Injuries

Brief summary

This project aims to evaluate an implementable screening tool and nutritional interventions that will lead to improved quality and patient safety. The aims of this pilot study are twofold: Purpose 1: assess the prognostic value of malnutrition and sarcopenia for identifying patients at increased risk of adverse postoperative outcomes following elective or semi-elective orthopedic procedures. Purpose 2: assess the clinical benefit of postoperative oral supplementation with a commercially-available nutritional supplement that includes conditionally-essential branched chain amino acids.

Detailed description

All patients will be treated according to standard of care for their orthopedic injuries, including standard nutritional support in the preoperative period. Patients admitted to our academic Level I trauma center with spinal fractures and sarcoma requiring limb reconstruction will be approached for consent to participate in this study. Consented patients will be prospectively enrolled at the time of admission. We will obtain relevant patient medical history, standard preoperative labs, radiographic imaging, and nutritional assessment at the time of admission. Patients will be assessed for the presence of sarcopenia utilizing ultrasound measures of skeletal muscle as previously described. All patients will be evaluated by a clinical dietitian or dietetic assistant for nutritional assessment as part of the standard of care. In addition to screening for sarcopenia and malnutrition, we will assess the clinical benefit of oral nutritional supplementation with essential branched-chain amino acids in a population of trauma patients. Patients providing written informed consent will be enrolled in a prospective RCT to assess nutritional supplementation with conditionally essential branched-chain amino acids. Patients will be randomly assigned to receive standard nutritional support or standard nutrition plus oral supplementation with a commercially available nutritional supplement containing essential branched chain amino acids (Juven, Abbot Nutrition). Similar combinations of essential amino acids have previously demonstrated protective effects against skeletal muscle wasting and medical complications in immobilized critically ill patients. Patients will be prospectively followed for 12 months from the time of admission to assess clinical outcomes. Our primary outcome measures include skeletal muscle mass changes, wound healing complications,

Interventions

DIETARY_SUPPLEMENTJuven

Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations.

Sponsors

Orthopaedic Trauma Association
CollaboratorOTHER
University of Iowa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* 18 years of age or older * Indicated for spinal or orthopedic oncology surgery

Exclusion criteria

* Unable to provide written consent * Unable to comply with postoperative treatment recommendations * Do not plan to follow up at the facility where surgery occurred * Food allergy to ingredients in dietary supplement * Intolerance to oral diet including phenylketonuria * Pregnant women * Individuals with dementia * Vulnerable populations (minors, prisoners) * Individuals lacking decision making capacity

Design outcomes

Primary

MeasureTime frameDescription
Body compositionOne yearChange in muscle mass

Secondary

MeasureTime frameDescription
Hand grip strengthOne yearChange in hand grip strength as measured by hand held dynamometer
Post-operative complicationsOne yearMedical and surgical complications following operative fracture fixation, validated patient

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026