Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA

NCT04910048 | Completed

• 1 other identifier: 262790
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

In this pilot study, we will test the hypothesis that a POPOP for currently ineligible UAMS orthopedic surgery patients wanting hip or knee replacement improves markers of preoperative health, ability to reach a BMI threshold \<40 kg/m2 required for surgical eligibility, and postoperative outcomes versus SOC.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Avascular Necrosis; Rheumatoid Arthritis

Keywords

Total joint arthroplasty; Hip arthroplasty; Knee arthroplasty; Surgical ineligibility; Obesity; Patient Reported Outcome Measures; TJA; THA; TKA; PROMs; BMI; HbA1c

Outcome Measures

Primary Outcomes (1)

• Change of pre-operative BMI

  Assessment of mean change in BMI (Body Mass Index, kg/m2) between the date of enrollment to follow-up visit to occur between days 70-110

  Approximately 70-110 days from study enrollment

Secondary Outcomes (14)

• Pre-operative health & nutritional status as assessed by change of red blood cell count

  Approximately 70-110 days from study enrollment

• Pre-operative health & nutritional status as assessed by change of white blood cell count

  Approximately 70-110 days from study enrollment

• Pre-operative health & nutritional status as assessed by change of platelet count

  Approximately 70-110 days from study enrollment

• Pre-operative health & nutritional status as assessed by change of albumin

  Approximately 70-110 days from study enrollment

• Pre-operative health & nutritional status as assessed by change of ALT (alanine aminotransferase)

  Approximately 70-110 days from study enrollment

Other Outcomes (9)

• Percentage of patients converting from ineligible to eligible status

  Approximately 70-110 days from study enrollment

• Percentage of patients who proceed to TJA

  Approximately 110-120 days from study enrollment

• Change of PROMs in the 6-weeks after knee replacement

  Approximately 180 days from study enrollment (or 6 weeks after TJA)

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

The first arm consists of UAMS standard of care (SOC), including providing a brochure with information (contact information, brief educational information) for the patient to consult with a nutritionist to help with self-directed weight loss.

Other: SOC (standard of care)

Intervention (POPOP)

EXPERIMENTAL

The second arm is a specified 2-month POPOP focused on weight loss administered by the external partner, 20Lighter. The program includes customized meal plans; vitamin, mineral and nutritional supplementation; and daily engagement via a smartphone app with a 20Lighter health care provider. Video conferencing appointments will occur approximately every 3 weeks. The program does not require any exercise or physical engagement but does necessitate that patients have a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection. During the first 40 days the customized meal plans are adhered to, then from days 41-60 patients will transition back to a normal dietary lifestyle via a customized plan based on considerations including, food preferences, physical engagement and height. Patients who achieve a BMI below 40.0 before the end of the 60 day program may be seen sooner than 90d for follow-up appointment in the UAMS clinic.

Other: POPOP (preoperative patient optimization program)

Interventions

POPOP (preoperative patient optimization program) OTHER

A 2 month structured program focused on reduction of BMI, body weight, visceral fat, body fat and improvement of lean body mass and intracellular fluid.

Also known as: 20Lighter

Intervention (POPOP)

SOC (standard of care) OTHER

Referral to a dietician for two months of self-directed weight loss

Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End-stage knee or hip osteoarthritis, avascular necrosis, or rheumatoid arthritis with recommended primary, unilateral total joint arthroplasty by orthopaedic surgeons at the University of Arkansas for Medical Sciences (Jeffrey Stambough, Dr. C. Lowry Barnes, Dr. Simon Mears, and Dr. Benjamin Stronach)
• BMI between 41.00-48.00 kg/m2 at time of enrollment
• Over the age of 18 years
• Would consider undergoing a total joint arthroplasty if eligible
• Owns a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection
• Willing to comply with the requirements of the study and provide informed consent prior to enrollment.

You may not qualify if:

• Patients with a BMI less than 41.00 or greater than 48.00
• Pregnancy
• Breastfeeding
• History of a major organ transplant or other health issue requiring immunosuppressant drugs
• Strict vegetarian diet
• Diagnosis of and/or are taking medication for psychiatric conditions including schizophrenia, bipolar disorder or manic depression
• Patients scheduled for, or those who have previously undergone, bariatric surgery
• Patients unable to understand and speak English
• Patients requiring a revision or bilateral TJA
• Patients unwilling or unable to use a bluetooth-enabled smartphone with cell service or home internet access
• Incarceration

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

UAMS Orthopaedic Clinic - Shackleford

Little Rock, Arkansas, 72211, United States

Location

Related Publications (10)

• Bolognesi MP, Marchant MH Jr, Viens NA, Cook C, Pietrobon R, Vail TP. The impact of diabetes on perioperative patient outcomes after total hip and total knee arthroplasty in the United States. J Arthroplasty. 2008 Sep;23(6 Suppl 1):92-8. doi: 10.1016/j.arth.2008.05.012.

  PMID: 18722309 BACKGROUND

• Boyce L, Prasad A, Barrett M, Dawson-Bowling S, Millington S, Hanna SA, Achan P. The outcomes of total knee arthroplasty in morbidly obese patients: a systematic review of the literature. Arch Orthop Trauma Surg. 2019 Apr;139(4):553-560. doi: 10.1007/s00402-019-03127-5. Epub 2019 Feb 16.

  PMID: 30778723 BACKGROUND

• Gerlach E, Selley R, Johnson D, Nicolay R, Versteeg G, Plantz M, Tjong V, Terry M. Patient-Reported Outcomes Measurement Information System Validation in Hip Arthroscopy: A Shift Towards Reducing Survey Burden. Cureus. 2021 Feb 10;13(2):e13265. doi: 10.7759/cureus.13265.

  PMID: 33728201 BACKGROUND

• Goodman SM, Mehta BY, Mandl LA, Szymonifka JD, Finik J, Figgie MP, Navarro-Millan IY, Bostrom MP, Parks ML, Padgett DE, McLawhorn AS, Antao VC, Yates AJ, Springer BD, Lyman SL, Singh JA. Validation of the Hip Disability and Osteoarthritis Outcome Score and Knee Injury and Osteoarthritis Outcome Score Pain and Function Subscales for Use in Total Hip Replacement and Total Knee Replacement Clinical Trials. J Arthroplasty. 2020 May;35(5):1200-1207.e4. doi: 10.1016/j.arth.2019.12.038. Epub 2019 Dec 27.

  PMID: 31952945 BACKGROUND

• Harold RE, Butler BA, Delagrammaticas D, Sullivan R, Stover M, Manning DW. Patient-Reported Outcomes Measurement Information System Correlates With Modified Harris Hip Score in Total Hip Arthroplasty. Orthopedics. 2021 Jan 1;44(1):e19-e25. doi: 10.3928/01477447-20201202-02. Epub 2020 Dec 7.

  PMID: 33284982 BACKGROUND

• Horn ME, Reinke EK, Couce LJ, Reeve BB, Ledbetter L, George SZ. Reporting and utilization of Patient-Reported Outcomes Measurement Information System(R) (PROMIS(R)) measures in orthopedic research and practice: a systematic review. J Orthop Surg Res. 2020 Nov 23;15(1):553. doi: 10.1186/s13018-020-02068-9.

  PMID: 33228699 BACKGROUND

• Keeney BJ, Austin DC, Jevsevar DS. Preoperative Weight Loss for Morbidly Obese Patients Undergoing Total Knee Arthroplasty: Determining the Necessary Amount. J Bone Joint Surg Am. 2019 Aug 21;101(16):1440-1450. doi: 10.2106/JBJS.18.01136.

  PMID: 31436651 BACKGROUND

• Lingamfelter M, Orozco FR, Beck CN, Harrer MF, Post ZD, Ong AC, Ponzio DY. Nutritional Counseling Program for Morbidly Obese Patients Enables Weight Optimization for Safe Total Joint Arthroplasty. Orthopedics. 2020 Jul 1;43(4):e316-e322. doi: 10.3928/01477447-20200521-08. Epub 2020 Jun 5.

  PMID: 32501522 BACKGROUND

• Shaka H, Ojemolon PE. Impact of Obesity on Outcomes of Patients With Hip Osteoarthritis Who Underwent Hip Arthroplasty. Cureus. 2020 Oct 10;12(10):e10876. doi: 10.7759/cureus.10876.

  PMID: 33178529 BACKGROUND

• Shapiro JA, Narayanan AS, Taylor PR, Olcott CW, Del Gaizo DJ. Fate of the Morbidly Obese Patient Who Is Denied Total Joint Arthroplasty. J Arthroplasty. 2020 Jun;35(6S):S124-S128. doi: 10.1016/j.arth.2020.01.071. Epub 2020 Feb 4.

  PMID: 32088050 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteonecrosis; Arthritis, Rheumatoid; Obesity

Interventions

POPOP; Standard of Care

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jeffrey B Stambough, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the interventions, masking or blinded participation is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two group randomized control trial comparing the intervention (POPOP) and standard of care (SOC).

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 2, 2021
• Study Start: January 17, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 3, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)