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

Rheumatoid Arthritis Clinical Trial

Official title:

Impact of a Preoperative Patient Optimization Program on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in Total Joint Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04910048
• Other study ID #: 262790
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: December 23, 2024

Study information

• Verified date: October 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After being informed about the study and potential risks, all patients giving written informed consent will be screened to determine eligibility for study entry. Patients who meet eligibility criteria will be randomized into one of two groups: Standard of Care or the POPOP (20Lighter).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 23, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Other:
• POPOP (preoperative patient optimization program)
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.
• SOC (standard of care)
Referral to a dietician for two months of self-directed weight loss

Locations

Country	Name	City	State
United States	UAMS Orthopaedic Clinic - Shackleford	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients converting from ineligible to eligible status	Assessment of the percentage of patients achieving a BMI of 40.0 kg/m2 or less in each treatment group	Approximately 70-110 days from study enrollment
Other	Percentage of patients who proceed to TJA	Assessment of the percentage of patients that undergo TJA in each treatment group	Approximately 110-120 days from study enrollment
Other	Change of PROMs in the 6-weeks after knee replacement	Assessment of change in the patient reported outcomes survey KOOS Jr, for patients undergoing knee replacement	Approximately 180 days from study enrollment (or 6 weeks after TJA)
Other	Change of PROMs in the 6-weeks after hip replacement	Assessment of change in the patient reported outcomes survey HOOS Jr, for patients undergoing hip replacement	Approximately 180 days from study enrollment (or 6 weeks after TJA)
Other	Change of PROMIS Pain Interference in the 6-weeks after joint replacement	Assessment of change in PROMIS Pain Interference patient reported outcome instrument	Approximately 180 days from study enrollment (or 6 weeks after TJA)
Other	Change of PROMIS Physical Function in the 6-weeks after joint replacement	Assessment of change in PROMIS Physical Function patient reported outcome instrument	Approximately 180 days from study enrollment (or 6 weeks after TJA)
Other	All-cause complication rate at 30-days post TJA	Rate of surgical complications requiring hospital readmission, ER or acute care visit in 30 days after TJA	Approximately 160 days from study enrollment (or 30 days after TJA)
Other	All-cause complication rate at 60-days post TJA	Rate of surgical complications requiring hospital readmission, ER or acute care visit in 60 days after TJA	Approximately 190 days from study enrollment (or 60 days after TJA)
Other	All-cause complication rate at 90-days post TJA	Rate of surgical complications requiring hospital readmission, ER or acute care visit in 90 days after TJA	Approximately 220 days from study enrollment (or 90 days after TJA)
Primary	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	Pre-operative health & nutritional status as assessed by change of red blood cell count	Change of values in red blood cells as assessed by (Complete Blood Count) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Pre-operative health & nutritional status as assessed by change of white blood cell count	Change of values in white blood cells as assessed by CBC (Complete Blood Count) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Pre-operative health & nutritional status as assessed by change of platelet count	Change of values in platelets as assessed by CBC (Complete Blood Count) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Pre-operative health & nutritional status as assessed by change of albumin	Change of values in Albumin as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Pre-operative health & nutritional status as assessed by change of ALT (alanine aminotransferase)	Change of values in ALT (alanine aminotransferase) as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Pre-operative health & nutritional status as assessed by change of AST (aspartate aminotransferase)	Change of values in AST (aspartate aminotransferase) as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Pre-operative health & nutritional status as assessed by change of BUN (blood urea nitrogen)	Change of values in BUN (blood urea nitrogen) as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Change of pre-operative health & nutritional status as assessed by Creatinine	Change of values in Creatinine as assessed by CMP (Comprehensive Metabolic Panel) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Change of pre-operative type 2 diabetes as assessed by HbA1c (Hemaglobin A1c) laboratory test values	Assessment of change in HbA1c (Hemaglobin A1c) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Change of pre-operative inflammation as assessed by CRP (C-Reactive Protein) laboratory test values	Assessment of change in CRP (C-Reactive Protein) between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Change of pre-operative PROMs (Knee Replacement)	Assessment of change in the patient reported outcomes survey KOOS Jr, knee replacement patients between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Change of pre-operative PROMs (Hip Replacement)	Assessment of change in the patient reported outcomes survey HOOS Jr, hip replacement patients between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Change of pre-operative PROMIS Pain Interference	Assessment of change in PROMIS Pain Interference patient reported outcome instrument between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment
Secondary	Change of pre-operative PROMIS Physical Function	Assessment of change in PROMIS Physical Function patient reported outcome instrument between the date of enrollment to follow-up visit to occur between days 70-110	Approximately 70-110 days from study enrollment