Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis

NCT ID: NCT04697667

Last Updated: 2022-02-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-02-10

Brief Summary

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This study is a prospective randomized controlled study of different treatments for knee osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma (PRP) injection versus only exercise or only PRP treatments.

Detailed Description

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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
Double

Study Groups

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Group I

Each subject in this group will receive a combined treatment protocol consisting of three PRP injections to knee joint and supervised exercise program.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Supervised exercise program

PRP

Intervention Type BIOLOGICAL

Intra-articular PRP injections to knee joint

Group II

Each subject in this group will receive a treatment of supervised exercise program.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Supervised exercise program

Group III

Each subject in this group will receive a treatment of three PRP injections to knee joint.

Group Type ACTIVE_COMPARATOR

PRP

Intervention Type BIOLOGICAL

Intra-articular PRP injections to knee joint

Interventions

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Exercise

Supervised exercise program

Intervention Type OTHER

PRP

Intra-articular PRP injections to knee joint

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults 40-70 years of age,
* Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
* No medication for knee osteoarthritis in the past three months,
* Subjects who understand and sign the consent form for this study.

Exclusion Criteria

* Patients who have received an invasive procedure, intra-articular application and / or physiotherapy in the target knee within three months,
* Previous partial or total knee replacement of the target knee,
* Body mass index \> 30 kg/m2,
* Having any cardiovascular diseases, neurological disorders, rheumatic diseases, malignancy or psychiatric diseases,
* Impaired cognition that impacts the ability to give informed consent,
* Participation in another clinical trial.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Sezen Karaborklu Argut

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TDK-2020-35062

Identifier Type: -

Identifier Source: org_study_id

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