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

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip, Avascular Necrosis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

POPOP (preoperative patient optimization program)

SOC (standard of care)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total joint arthroplasty, Hip arthroplasty, Knee arthroplasty, Surgical ineligibility, Obesity, Patient Reported Outcome Measures, TJA, THA, TKA, PROMs, BMI, HbA1c

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UAMS Orthopaedic Clinic - ShacklefordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Intervention (POPOP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT04910048

First Posted

May 20, 2021

Last Updated

October 16, 2023

Sponsor

University of Arkansas

1. Study Identification

Unique Protocol Identification Number

NCT04910048

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 17, 2022 (Actual)

Primary Completion Date

January 16, 2024 (Anticipated)

Study Completion Date

January 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

Due to the nature of the interventions, masking or blinded participation is not possible.

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Arm Title

Intervention (POPOP)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

POPOP (preoperative patient optimization program)

Other Intervention Name(s)

20Lighter

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

SOC (standard of care)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of pre-operative BMI

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

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

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

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

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

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

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

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

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

Pre-operative health & nutritional status as assessed by change of AST (aspartate aminotransferase)

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

Pre-operative health & nutritional status as assessed by change of BUN (blood urea nitrogen)

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

Change of pre-operative health & nutritional status as assessed by Creatinine

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

Change of pre-operative type 2 diabetes as assessed by HbA1c (Hemaglobin A1c) laboratory test values

Description

Assessment of change in HbA1c (Hemaglobin A1c) between the date of enrollment to follow-up visit to occur between days 70-110

Time Frame

Approximately 70-110 days from study enrollment

Title

Change of pre-operative inflammation as assessed by CRP (C-Reactive Protein) laboratory test values

Description

Assessment of change in CRP (C-Reactive Protein) between the date of enrollment to follow-up visit to occur between days 70-110

Time Frame

Approximately 70-110 days from study enrollment

Title

Change of pre-operative PROMs (Knee Replacement)

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

Change of pre-operative PROMs (Hip Replacement)

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

Change of pre-operative PROMIS Pain Interference

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Title

Change of pre-operative PROMIS Physical Function

Description

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

Time Frame

Approximately 70-110 days from study enrollment

Other Pre-specified Outcome Measures:

Title

Percentage of patients converting from ineligible to eligible status

Description

Assessment of the percentage of patients achieving a BMI of 40.0 kg/m2 or less in each treatment group

Time Frame

Approximately 70-110 days from study enrollment

Title

Percentage of patients who proceed to TJA

Description

Assessment of the percentage of patients that undergo TJA in each treatment group

Time Frame

Approximately 110-120 days from study enrollment

Title

Change of PROMs in the 6-weeks after knee replacement

Description

Assessment of change in the patient reported outcomes survey KOOS Jr, for patients undergoing knee replacement

Time Frame

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

Title

Change of PROMs in the 6-weeks after hip replacement

Description

Assessment of change in the patient reported outcomes survey HOOS Jr, for patients undergoing hip replacement

Time Frame

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

Title

Change of PROMIS Pain Interference in the 6-weeks after joint replacement

Description

Assessment of change in PROMIS Pain Interference patient reported outcome instrument

Time Frame

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

Title

Change of PROMIS Physical Function in the 6-weeks after joint replacement

Description

Assessment of change in PROMIS Physical Function patient reported outcome instrument

Time Frame

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

Title

All-cause complication rate at 30-days post TJA

Description

Rate of surgical complications requiring hospital readmission, ER or acute care visit in 30 days after TJA

Time Frame

Approximately 160 days from study enrollment (or 30 days after TJA)

Title

All-cause complication rate at 60-days post TJA

Description

Rate of surgical complications requiring hospital readmission, ER or acute care visit in 60 days after TJA

Time Frame

Approximately 190 days from study enrollment (or 60 days after TJA)

Title

All-cause complication rate at 90-days post TJA

Description

Rate of surgical complications requiring hospital readmission, ER or acute care visit in 90 days after TJA

Time Frame

Approximately 220 days from study enrollment (or 90 days after TJA)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffrey B Stambough, MD

Phone

501-686-7812

jstambough@uams.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey B Stambough, MD

Organizational Affiliation

University of Arkansas

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAMS Orthopaedic Clinic - Shackleford

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Principal Investigator

First Name & Middle Initial & Last Name & Degree

C. Lowry Barnes, MD

First Name & Middle Initial & Last Name & Degree

Benjamin Stronach, MD

First Name & Middle Initial & Last Name & Degree

Simon Mears, MD PHD

First Name & Middle Initial & Last Name & Degree

Jessica W Barnes, PHD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data will not be shared. Statistics based on aggregated de-identified data will be assessed, and disseminated at industry conferences and peer-reviewed publication.

Citations:

PubMed Identifier

18722309

Citation

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.

Results Reference

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PubMed Identifier

30778723

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.

Results Reference

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PubMed Identifier

33728201

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.

Results Reference

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PubMed Identifier

31952945

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.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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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.

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Citation

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Citation

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

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