PRP Effectiveness in Knee Osteoarthritis

NCT ID: NCT04807270

Last Updated: 2021-03-19

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2021-12-01

Brief Summary

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The aim of our study is to determine the effects of intra-articular Platelet Rich Plasma (PRP) prepared with two different techniques on pain intensity, functional status, quality of life, functional balance and femoral cartilage thickness in patients with knee osteoarthritis.

Detailed Description

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Osteoarthritis (OA) is the most common form of chronic joint disease. Platelet Rich Plasma (PRP) is an injection therapy used to treat chronic painful musculoskeletal conditions, including knee OA. In this prospective, randomized controlled, single blind, interventional study, a total of 75 patients with stage 2-3 knee osteoarthritis according to the kellgren lawrence classification who meet the eligibility criteria will be enrolled in the study. Eligible participants will be randomly assigned to one of the three groups using computer-generated random numbers.The patients to be included in the study will be randomized into three groups and the first group will be given platelet-rich plasma (PRP) prepared with T-LAB / PRP KIT, the second group will be given PRP prepared with T-LAB PRP INJECTION SYRINGA, and the third group will be given saline injection. Home exercise program for knee osteoarthritis will be given to all three groups and the exercise program will be followed by weekly phone calls. During the follow-up period, patients will be asked to continue their current medical treatments, not to make changes in their activities of daily living. Participants are going to evaluate before injection, and at the 1-month follow-up and 6-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change in pain, stiffness and physical function score, the change in the Timed Up and Go Test (TUG) time, change in femoral cartilage thickness measurement by ultrasound and the change in the patient's daily activities with the numerical global patient assessment scale.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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T-LAB / PRP KIT

In the first group, Platelet-rich plasma (PRP) prepared with T-LAB / PRP KIT injection in 3 sessions will be applied.

Group Type ACTIVE_COMPARATOR

Intra-articular T-LAB / PRP KIT injection

Intervention Type OTHER

Intra-articular 3 ml T-LAB / PRP KIT injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

T-LAB / PRP INJECTION SYRINGE

In the first group, Platelet-rich plasma (PRP) prepared with T-LAB / PRP INJECTION SYRINGE injection in 3 sessions will be applied.

Group Type ACTIVE_COMPARATOR

Intra-articular T-LAB / PRP INJECTION SYRINGE injection

Intervention Type OTHER

Intra-articular 3 ml T-LAB / PRP INJECTION SYRINGE injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

SALINE

In the first group, Platelet-rich plasma (PRP) prepared with SALINE injection in 3 sessions will be applied.

Group Type ACTIVE_COMPARATOR

Intra-articular SALINE injection

Intervention Type OTHER

Intra-articular 3 ml SALINE injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

Interventions

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Intra-articular T-LAB / PRP KIT injection

Intra-articular 3 ml T-LAB / PRP KIT injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

Intervention Type OTHER

Intra-articular T-LAB / PRP INJECTION SYRINGE injection

Intra-articular 3 ml T-LAB / PRP INJECTION SYRINGE injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

Intervention Type OTHER

Intra-articular SALINE injection

Intra-articular 3 ml SALINE injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic symptomatic knee pain between the ages of 30-75 years
* Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
* Functional ambulation scale stage 4-5

Exclusion Criteria

* Intra-articular knee injection within the last six months
* History of severe trauma to the knee within the past six months
* Concomitant severe meniscus or ligament injury, surgery applied to the knee area
* Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
* Having a bleeding disorder and / or using warfarin
* Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
* Presence of cardiac or systemic disease that may affect exercise
* The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
* Body Mass Index ≥35 kg / m²
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Sinan GOK

MD, Sub-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Demirhan Diracoglu, Prof.

Role: STUDY_DIRECTOR

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Ekin I Sen, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Locations

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Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatıh, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sinan Gok, MD

Role: CONTACT

+902124142000 ext. 12856

Yunus Emre Dogan, MD

Role: CONTACT

+902124142000 ext. 12856

Facility Contacts

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Sinan Gok, MD

Role: primary

+902124142000 ext. 12856

Ekin I Sen, Asst. Prof.

Role: backup

+902124142000 ext. 12856

Other Identifiers

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Istanbul Universty PRP

Identifier Type: -

Identifier Source: org_study_id

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