Osteoarthritis, KneeNCT04910048
Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA
A study testing POPOP (preoperative patient optimization program) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Avascular Necrosis
- What is being tested?
- POPOP (preoperative patient optimization program)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2022to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UAMS Orthopaedic Clinic - Shackleford
Little Rock, Arkansas, 72211
About this study
Official title: Impact of a Preoperative Patient Optimization Program on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in Total Joint Arthroplasty
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.
Read the 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).
- Being tested
- POPOP (preoperative patient optimization program), SOC (standard of care)
- Keywords
- Total joint arthroplasty, Hip arthroplasty, Knee arthroplasty, Surgical ineligibility, Obesity, Patient Reported Outcome Measures, TJA, THA, TKA, PROMs, BMI, HbA1c
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteonecrosis, Arthritis, Rheumatoid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POPOP (preoperative patient optimization program)Other
Also called 20Lighter
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)Other
Referral to a dietician for two months of self-directed weight loss
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: POPOP (preoperative patient optimization program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 70-110 days from study enrollment
Secondary outcomes (14)
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
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
Measured: Approximately 70-110 days from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start17 Jan 2022
- Primary completion1 Apr 2023
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group randomized control trial comparing the intervention (POPOP) and standard of care (SOC).
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Stambough, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910048
- Sponsor's protocol ID
- 262790
- Status last verified
- Sep 2024
- First submitted
- 20 May 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 18722309Boyce 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.
PubMed 30778723Gerlach 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.
PubMed 33728201Goodman 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.
PubMed 31952945Harold 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.
PubMed 33284982Horn 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.
PubMed 33228699Keeney 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.
PubMed 31436651Lingamfelter 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.
PubMed 32501522Shaka 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.
PubMed 33178529Shapiro 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.
PubMed 32088050
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Preoperative Patient Optimization Program on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT04910048
- Acronym / sponsor ID
- 262790
- Keywords
- Total joint arthroplasty, Hip arthroplasty, Knee arthroplasty, Surgical ineligibility, Obesity, Patient Reported Outcome Measures, TJA, THA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group randomized control trial comparing the intervention (POPOP) and standard of care (SOC).
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: SOC (standard of care)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. |
| Intervention (POPOP) | Experimental | Other: POPOP (preoperative patient optimization program)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POPOP (preoperative patient optimization program)Also: 20LighterA 2 month structured program focused on reduction of BMI, body weight, visceral fat, body fat and improvement of lean body mass and intracellular fluid. | Other | Intervention (POPOP) |
| SOC (standard of care)Referral to a dietician for two months of self-directed weight loss | Other | Standard of Care |
Primary outcome
Change of pre-operative BMI
Time frame: Approximately 70-110 days from study enrollment
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
14 secondary outcomes
Pre-operative health & nutritional status as assessed by change of red blood cell count
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of white blood cell count
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of platelet count
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of albumin
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of ALT (alanine aminotransferase)
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of AST (aspartate aminotransferase)
Time frame: Approximately 70-110 days from study enrollment
Pre-operative health & nutritional status as assessed by change of BUN (blood urea nitrogen)
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative health & nutritional status as assessed by Creatinine
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative type 2 diabetes as assessed by HbA1c (Hemaglobin A1c) laboratory test values
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative inflammation as assessed by CRP (C-Reactive Protein) laboratory test values
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative PROMs (Knee Replacement)
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative PROMs (Hip Replacement)
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative PROMIS Pain Interference
Time frame: Approximately 70-110 days from study enrollment
Change of pre-operative PROMIS Physical Function
Time frame: Approximately 70-110 days from study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 18722309Bolognesi 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.
- Background: PubMed 30778723Boyce 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.
- Background: PubMed 33728201Gerlach 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.
- Background: PubMed 31952945Goodman 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.
- Background: PubMed 33284982Harold 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.
- Background: PubMed 33228699Horn 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.
- Background: PubMed 31436651Keeney 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.
- Background: PubMed 32501522Lingamfelter 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.
- Background: PubMed 33178529Shaka 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.
- Background: PubMed 32088050Shapiro 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey B Stambough, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POPOP (preoperative patient optimization program) in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pre-operative BMI (time frame: Approximately 70-110 days from study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910048, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.