Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty

NCT ID: NCT03758183

Last Updated: 2018-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-10-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

two-stage algorithm

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

total knee arthroplasty

Intervention Type PROCEDURE

one-stage algorithm

total knee arthroplasty (TKA)

total knee arthroplasty

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

total knee arthroplasty

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

injection prolotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tokat State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Serkan Akpancar

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Serkan Akpancar, Dr

Role: STUDY_DIRECTOR

Tokat State Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Serkan Akpancar

Tokat Province, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TokatSH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Comparative Study of Knee Systems
NCT01331278 COMPLETED PHASE4