Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Wounds and Injuries

Rare Diseases

Malnutrition

Sarcoma

Spinal Injuries

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Nutrition Disorders

Back Injuries

Soft Tissue Sarcoma

Analgesics

All Drugs and Chemicals

Subjects in this group will be asked to consume the nutritional supplement on a daily basis, in addition to standard nutrition. Subjects will have pain medication and postoperative therapies per standard of care.

Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care.

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

Juven

Nathan Hendrickson, MD

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.

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,

Spine and Tumor Screening and Supplementation

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

Change in hand grip strength as measured by hand held dynamometer

Medical and surgical complications following operative fracture fixation, validated patient

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Spine and Tumor Screening and Supplementation	NCT03660540	Spinal Injuries Sarcoma Nutritional Def...	Juven	18 Years - 100 Years	University of Iowa
Spine and Tumor Screening and Supplementation	NCT03660540	Spinal Injuries Sarcoma Nutritional Def...	Juven	18 Years - 100 Years	University of Iowa

Spots Global Cancer Trial Database for spinal injuries