Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: total knee arthroplasty

• Registration Number: NCT03758183
• Lead Sponsor: Tokat State Hospital

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.

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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2018-10-24
• Status Verified: 2018-11
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Study First Posted: 2018-11-29
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)	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.

Trial Locations

Locations (1)

Serkan Akpancar; 🇹🇷 Tokat, Turkey