Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty

NCT03758183 | Completed

• 1 other identifier: TokatSH
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Arthroplasty; Prolotherapy; Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

two-stage algorithm

Prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)

Procedure: total knee arthroplasty

one-stage algorithm

total knee arthroplasty (TKA)

Procedure: total knee arthroplasty

Interventions

total knee arthroplasty PROCEDURE

Also known as: injection, prolotherapy

one-stage algorithm; two-stage algorithm

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Age of the patients varied between 50 and 90

You may qualify if:

• 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) -

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat State Hospital: lead

Study Sites (1)

Serkan Akpancar

Tokat Province, 60060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee; Injections; Prolotherapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Drug Administration Routes; Drug Therapy; Therapeutics; Complementary Therapies

Study Officials

• Serkan Akpancar, Dr

  Tokat State Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 29, 2018
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: October 24, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

TU (1)