Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty

An observational study of Knee Osteoarthritis, run by Tokat State Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 50 to 70 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: total knee arthroplasty
Type of treatment: Injection or infusion, Surgery or procedure
How many people: 197 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2016to 24 Oct 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Age of the patients varied between 50 and 90

Who may be able to join

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) -

Who cannot join

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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Serkan Akpancar
Tokat Province, 60060

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Conditions: Knee Osteoarthritis
Being tested: total knee arthroplasty
Keywords: Arthroplasty, Prolotherapy, Osteoarthritis
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

total knee arthroplastyProcedure or surgery
Also called injection, prolotherapy

Study groups in NCT03758183
Study group	Role	What they receive
two-stage algorithm		Prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA) Receives: Procedure: total knee arthroplasty
one-stage algorithm		total knee arthroplasty (TKA) Receives: Procedure: total knee arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201624 Oct 2018

First posted29 Nov 2018
Study start1 Jan 2016
Primary completion1 Jan 2017
Study completion24 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03758183
Sponsor's protocol ID: TokatSH
Status last verified: Nov 2018
First submitted: 8 Nov 2018
Last updated: 29 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All primary and secondary data will be made available.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cost Effectiveness of Two-stage Algorithm (Prolotherapy Injections Prior to Total Knee Arthroplasty) in the Management of Advanced Stage Knee Osteoarthritis
ClinicalTrials.gov ID: NCT03758183
Acronym / sponsor ID: TokatSH
Conditions: Knee Osteoarthritis
Keywords: Arthroplasty, Prolotherapy, Osteoarthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: Tokat State HospitalOther government
Study start: 1 Jan 2016 (actual)
Primary completion: 1 Jan 2017 (actual)
Study completion: 24 Oct 2018 (actual)
First posted: 29 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
two-stage algorithm	–	Procedure: total knee arthroplastyProlotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)
one-stage algorithm	–	Procedure: total knee arthroplastytotal knee arthroplasty (TKA)

Who may qualify

Ages: 50 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Age of the patients varied between 50 and 90

Key inclusion criteria (2 listed)

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) -

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
total knee arthroplastyAlso: injection, prolotherapy	Procedure or surgery	one-stage algorithm, two-stage algorithm

Primary outcome

Visual Analog Scale (VAS)
Time frame: 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)
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
Individual participant dataSharing planned: Yes. All primary and secondary data will be made available.

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Serkan Akpancar, Dr study director

Tokat State Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis, run by Tokat State Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03758183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.