Spine and Tumor Screening and Supplementation

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Sarcoma; Spinal Injuries; Nutritional Deficiency
• Intervention / Treatment: Dietary supplement: Juven

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,

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional supplement group; 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.	Dietary supplement: Juven; Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations.
No Intervention: Standard nutrition group; Subjects in this group will have standard nutrition provided per dietitian recommendation. Subjects will have pain medication and postoperative therapies per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Change in muscle mass	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip strength	Change in hand grip strength as measured by hand held dynamometer	One year
Post-operative complications	Medical and surgical complications following operative fracture fixation, validated patient	One year

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: Orthopaedic Trauma Association

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Wounds and Injuries; Nutrition Disorders; Back Injuries; Sarcoma; Malnutrition; Spinal Injuries
• Other Study ID Numbers: 201805970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No