Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cost Effectiveness of Two-stage Algorithm (Prolotherapy Injections Prior to Total Knee Arthroplasty) in the Management of Advanced Stage Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| two-stage algorithm<br>Prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA) | Procedure: total knee arthroplasty<br> <br> * Other names: prolotherapy;|
| one-stage algorithm<br>total knee arthroplasty (TKA) | Procedure: total knee arthroplasty<br> <br> * Other names: prolotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | 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. | 18 months | 
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 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. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Prolotherapy, Osteoarthritis