Last reviewed · How we verify
NCT06734845: ESPI-PRO
Energy Status and Protein Intake As Prognostic Indicators of Rehabilitative Outcomes
trial testing Total Knee Arthroplasty in Orthopedic in 38 participants. Completed in 1 October 2023.
1 October 2023
Quick facts
| Lead sponsor | University of Connecticut |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 38 |
| Start date | 10 January 2023 |
| Primary completion | 1 October 2023 |
| Estimated completion | 1 October 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Total Knee Arthroplasty — full drug profile →
- Total Joint Arthroplasty
Conditions studied
- Orthopedic — all drugs for Orthopedic →
- Osteo Arthritis Knee — all drugs for Osteo Arthritis Knee →
- Hip Osteoarthritis — all drugs for Hip Osteoarthritis →
- Protein-Energy Malnutrition — all drugs for Protein-Energy Malnutrition →
Sponsor
University of Connecticut
Who can join
Adults 50 to 70, any sex, with Orthopedic or Osteo Arthritis Knee. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The proposed project is novel in its goal to establish a foundation for evidence-based rehabilitative nutrition guidelines to enhance perioperative patient care and improve post-operative rehabilitative outcomes specific to muscle health (muscle mass, strength, and function) and quality of life in elective orthopedic surgery patients undergoing total joint replacement procedures. Study Aims. Specific aims and their respective approach for the proposed investigation were: Aim 1: Characterize energy status and protein intake in total hip arthroplasty and total knee arthroplasty patients prior to surgery. Approach. Following approval of investigation by the Hartford Hospital Institution Review Board, data collection involved the inclusion of a research information sheet and a 3-day food record with instructions for the respective patient to complete prior to surgery. Aim 2: Evaluate association between energy status, positive or negative energy balance on standard outcome measures assessed throughout physical rehabilitation to determine whether energy status and protein intake at admission predicts objective and subjective rehabilitative outcome measures. Dietary assessments (3-day food record, protein screener) occurred at time points corresponding to physical rehabilitative assessments per approach for Aim 1. Approach. Total Hip Replacement assessments will occur between Day 1 following surgery and Week 2 and 6 months post surgery . Outcome measures included Pain Visual Analog Scale, Hip Disability Osteoarthritis Outcome Score, Timed Up and Go Test, 30 second Sit to Stand Test, Passive Hip Range of Motion and Active Hip Range of Motion. Total knee assessments were taken post surgery on between Day 1 and Week 2 and at 4 to 6 Weeks, and 7 to 12 Weeks following surgery. These included Pain Visual Analog Scale, Knee Injury and Osteoarthritis Outcome Score, Timed Up and Go test, 30-second Sit to Stand Test, Passive and Active Knee Range of Motion, and Knee Strength. Aim 3: Validate a protein screener developed by our research team and designed to characterize protein intake and protein source was administered pre- and post-operatively. For the latter, time points were established according to respective treatment guidelines for Total Hip and Total Knee replacement patients, respectively.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06734845
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Total Knee Arthroplasty
Trials testing the same drug.
- NCT07009912 — ROSA® Knee System V1.5 Pilot Study · NA · completed
- NCT07310303 — Simulation-Based Preoperative Education in Total Knee Arthroplasty · NA · recruiting
- NCT06627673 — MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design · NA · not yet recruiting
- NCT06627699 — Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® · not yet recruiting
- NCT05575310 — Central Sensitization in Total Knee Arthroplasty Patients with Persistent Pain · completed
Other University of Connecticut trials
Trials by the same sponsor.
- NCT06794840 — JomCare Study - A Harm Reduction Study · NA · not yet recruiting
- NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
- NCT06381921 — Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain · NA · recruiting
- NCT06393725 — Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions · NA · recruiting
- NCT04989309 — Left and Right Hemisphere Contributions to Speech Perception · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06734845 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Connecticut
- Last refreshed: 16 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06734845.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing