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Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03758183
Recruitment Status : Completed
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Serkan Akpancar, Tokat State Hospital

Study Description
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Brief Summary:
This study compared the cost effectiveness of two-stage algorithm (prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)) and one-stage algorithm (TKA) in the management of advanced stage knee osteoarthritis.

Condition or disease Intervention/treatment
Knee Osteoarthritis Procedure: total knee arthroplasty

Detailed Description:

The aim of the present study was to compare the cost effectiveness of two-stage algorithm (prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)) and one-stage algorithm (TKA) in the management of advanced stage knee osteoarthritis.

A total of 197 patients who had chronic knee osteoarthritis were included in the present study. The patients were divided into two groups as two-stage algorithm (PrT combined with RP prior to TKA), (Group A, n=98) and one-stage (TKA),(Group B, n=99). Clinical effectiveness was evaluated via Visual Analog Scale (VAS), The Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and 3-, 6-, 12-, and 18-month follow-ups. Utility scores of the groups were obtained by extracting and converting WOMAC scores to health utilities index mark 3 scores. Cost-utility per quality-adjusted life years (QALY) and Incremental cost-effectiveness ratios (ICERs) of each group were calculated.

Study Design
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Study Type : Observational
Actual Enrollment : 197 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cost Effectiveness of Two-stage Algorithm (Prolotherapy Injections Prior to Total Knee Arthroplasty) in the Management of Advanced Stage Knee Osteoarthritis
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : October 24, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
two-stage algorithm
Prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)
 Procedure: total knee arthroplasty
Other Names:
  • injection
  • prolotherapy
one-stage algorithm
total knee arthroplasty (TKA)
 Procedure: total knee arthroplasty
Other Names:
  • injection
  • prolotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 18 months ]
    Self reported pain intensity. Each item is scored 0-10 (0=no pain; 10= pain as bad as can be), yielding a total between 0 and 10.

  2. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 18 months ]

    Self-administered questionnaire consisting of 24 items divided into 3 subscales:

    Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. Each item is scored 0-96 (0=minimum; 96= as bad as can be), yielding a total between 0 and 96.



Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Age of the patients varied between 50 and 90
Criteria

Inclusion Criteria:

  • III and IV levels of knee osteoarthritis according to Kellgren-Lawrence
  • Had at least six months of symptoms resistant to at least three months of conservative methods (lifestyle modification, weight reduction, regular exercise, physiotherapy, non-steroidal anti-inflammatory drugs, intraarticular injection methods) -

Exclusion Criteria:

  • With rheumatic diseases, immune diseases or other systemic inflammatory diseases
  • With active infection, osteomyelitis or history of chronic infection around knee joint
  • Had undergone previous operation on knee
  • Had bleeding tendency (hereditary or acquired)
  • Pregnant patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758183


Locations
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Turkey
Serkan Akpancar
Tokat, Turkey, 60060
Sponsors and Collaborators
Tokat State Hospital
Investigators
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Study Director: Serkan Akpancar, Dr Tokat State Hospital
More Information
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Responsible Party: Serkan Akpancar, Dr, Tokat State Hospital
ClinicalTrials.gov Identifier: NCT03758183    
Other Study ID Numbers: TokatSH
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All primary and secondary data will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available with in 3 months of the study completed
Access Criteria: Data will be reviewed by external independent review panel. Requesters will be required to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Serkan Akpancar, Tokat State Hospital:
Arthroplasty
Prolotherapy
Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases