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Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty

T

Tokat State Hospital

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Procedure: total knee arthroplasty

Study type

Observational

Funder types

Other

Identifiers

NCT03758183
TokatSH

Details and patient eligibility

About

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.

Full 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.

Enrollment

197 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

197 participants in 2 patient groups

two-stage algorithm
Description:
Prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)
Treatment:
Procedure: total knee arthroplasty
one-stage algorithm
Description:
total knee arthroplasty (TKA)
Treatment:
Procedure: total knee arthroplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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