NCT04697667

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

January 31, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

January 3, 2021

Last Update Submit

February 26, 2026

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (8)

  • Pain intensity

    Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.

    6th week

  • Pain intensity

    Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.

    3rd month

  • Function

    Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.

    6th week

  • Functional performance - 40m fast-paced walk test

    Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).

    6th week

  • Functional performance - 10-step stair-climb test

    Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.

    6th week

  • Function

    Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.

    3rd month

  • Functional performance - 40m fast-paced walk test

    Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).

    3rd month

  • Functional performance - 10-step stair-climb test

    Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.

    3rd month

Secondary Outcomes (6)

  • Range of motion

    6th week

  • Range of motion

    3rd month

  • Health related quality of life

    6th week

  • Health related quality of life

    3rd month

  • Patient Satisfaction

    6th week

  • +1 more secondary outcomes

Study Arms (3)

Group I

EXPERIMENTAL

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

Other: ExerciseBiological: PRP

Group II

ACTIVE COMPARATOR

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

Other: Exercise

Group III

ACTIVE COMPARATOR

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

Biological: PRP

Interventions

ExerciseOTHER

Supervised exercise program

Group IGroup II
PRPBIOLOGICAL

Intra-articular PRP injections to knee joint

Group IGroup III

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Karaborklu Argut S, Celik D, Ergin ON, Kilicoglu OI. Does the Combination of Platelet-rich Plasma and Supervised Exercise Yield Better Pain Relief and Enhanced Function in Knee Osteoarthritis? A Randomized Controlled Trial. Clin Orthop Relat Res. 2024 Jun 1;482(6):1051-1061. doi: 10.1097/CORR.0000000000002993. Epub 2024 Feb 6.

    PMID: 38323999RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 3, 2021

First Posted

January 6, 2021

Study Start

January 31, 2021

Primary Completion

January 7, 2022

Study Completion

February 10, 2022

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

TU(1)