PRP Effectiveness in Knee Osteoarthritis

NCT04807270 | Completed

• 1 other identifier: Istanbul Universty PRP
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• Change from baseline activity pain score at 1-months, 3-months and 6-months

  Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome

  Baseline, 1-month, 3-month, 6-month

Secondary Outcomes (5)

• Change from baseline activity pain score at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline pain, stiffness and physical function at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline quality of life and global assessment at 1-months, 3-months and 6-months

  Baseline, 1-month, 3-month, 6-month

• Change from baseline functional balance at 3-months and 6-months

  Baseline, 3-month, 6-month

• Change from baseline femoral cartilage thickness measurement by ultrasound at 6 months

  Baseline, 6-month

Study Arms (3)

T-LAB / NEXT PRP SYRINGE

ACTIVE COMPARATOR

In the first group (PRP1 group; non-anticoagulant pure PRP), prepared with Next PRP Syringe in 3 sessions will be applied.

Other: Intra-articular T-LAB / Next PRP Syringe

T-LAB / PRP KIT

ACTIVE COMPARATOR

In the second group (PRP2 group; amber PRP) prepared with T-LAB / PRP KIT in 3 sessions will be applied.

Other: Intra-articular T-LAB / PRP KIT injection

SALINE

SHAM COMPARATOR

In the third group (saline group), prepared with SALINE in 3 sessions will be applied.

Other: Intra-articular SALINE injection

Interventions

Intra-articular T-LAB / PRP KIT injection OTHER

PRP containing anticoagulant will be prepared using T-LAB / PRP KIT. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

T-LAB / PRP KIT

Intra-articular SALINE injection OTHER

Similar to the PRP protocol, 4 mL of 0.9% sodium chloride will be injected intra-articularly. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

SALINE

Intra-articular T-LAB / Next PRP Syringe OTHER

Anticoagulant-free pure PRP will be prepared using T-LAB / Next PRP Syringe. 4 ml of PRP will be injected intra-articularly three times at 2-week intervals. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, and short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.

T-LAB / NEXT PRP SYRINGE

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic symptomatic knee pain between the ages of 30 and 75 years
• Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
• The ability to walk independently

You may not qualify if:

• Previous treatment with an autologous blood product or stem cell preparation
• Severe knee effusion
• Concomitant severe meniscus or ligament injury
• Recent cancer or other tumors
• History of knee surgery
• Previous diagnosis of a neuromuscular, infectious, or inflammatory disease
• Bleeding disorders and/or use of warfarin
• Body mass index above 40 kg/m²
• Cardiac or systemic diseases that could affect participation in the exercise program

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

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

Istanbul, Fatıh, 34034, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Demirhan Diracoglu, Prof.

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

  STUDY DIRECTOR

• Ekin I Sen, Asst. Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Sub-Investigator

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: May 20, 2021
• Primary Completion: November 20, 2022
• Study Completion: January 1, 2023
• Last Updated: May 22, 2026

Record last verified: 2023-03

Locations

TU (1)