PRP vs HA Intra-articular Knee Injections for Cartilage Defects

NCT02012530 | Unknown DMC

• 1 other identifier: SKRF 003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Study Title: A cohort comparison study Comparing Platelet Rich Plasma vs Hyaluronic Acid Intra-articular Knee Injections for Early Cartilage Defects in the knee. Study hypothesis: We start with the hypothesis that both treatments are equally effective. Trial Design: The participating patients will be divided into two groups, each group receiving either one of the treatment modalities. This study will be randomised. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty. The post-operative rehabilitation process will be the same for both groups. Trial Participants: All participants will be from patients attending Professor Shetty's clinic at the Spire Alexandra Hospital. Planned Sample Size: 50 patients in each group Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3 months following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores. Planned Trial Period: Two to three years Primary Objective: To establish superiority, if any, of either procedure over the other by studying pain relief, improvement in function. Primary Endpoint: At the end of the 2 year follow up for all participating patients.

Conditions

Osteoarthritis

Keywords

Articular cartilage; Hyaluronic Acid (HA); Platelet rich plasma (PRP)

Outcome Measures

Primary Outcomes (1)

• Clinical outcome

  The participating patients will be followed up at 2 weeks, 6 weeks and finally at 3 months following the injection by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by KOOS score.

  3 months

Secondary Outcomes (1)

• Change in VAS Score at 3 months

  3 months

Study Arms (2)

HA

ACTIVE COMPARATOR

Patients in this arm will have hyaluronic acid (HA) injected into their knee along with 3 ml local anaesthetic. The HA injection is in the form of 2 ml aqueous sodium hyaluronate. The exact constituents of the HA change in a proprietary manner. All HA injections used will have the CE marking on them.

Procedure: HA

PRP

ACTIVE COMPARATOR

Patients in this arm will have platelet rich plasma (PRP) injected into their knee. The PRP sample will be produced at the time of the injection. 30 ml of blood is drawn fro the patient a few minutes before the injection. Using a CE marked differential centrifugation device, the platelets are isolated. This concentrated sample of platelets is injected into the knee after the skin around the injection site is anaesthetised with local anaesthetic.

Procedure: PRP

Interventions

HA PROCEDURE

HA is widely applied in clinical practice with good results in many studies. HA forms part of the inflammatory process that can lead to the regeneration of cartilage in defective areas of the knee.

HA

PRP PROCEDURE

PRP uses reparative growth factors taken from the patient's own blood to create an environment in the knee conducive to wound healing that can fill cartilage defects. It's autologous origin, easy preparation and safety profile makes it a potentially ground breaking treatment option for knee cartilage defects and osteoarthritis.

PRP

Eligibility Criteria

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

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Diagnosed with either early degenerative cartilage lesions (Grade 1-3) as determined by plain radiograph, MRI or intra-operatively (categorised as per Outerbridge/ICRS classification).
• The patient must have more than a four month history of knee pain or swelling whether continuous or intermittent.

You may not qualify if:

• Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
• Systemic disorders- DM, RA, SLE
• Major axial deviation (varus\>5˚, valgus\>5˚)
• Patients suffering from haematological disorders (coagulopathy)
• Patients with severe cardiovascular disease
• Active infection
• Immuno-suppressed patients
• Patients taking anticoagulants such warfarin or low molecular weight heparin
• Haemoglobin levels below 11g/dl
• Platelet count below 150000/mmc
• Participants who have participated in another research study involving an investigational product in the past 12 weeks

Sponsors & Collaborators

• Shetty-Kim Research Foundation: lead

Study Sites (1)

Kent Knee Unit

Walderslade, Kent, ME5 9PG, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Asode A Shetty, MD, MCh, PhD, FRCS

  Canterbury Christ Church University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asode A Shetty, MD, PhD, MCh, FRCS

CONTACT

01634 662813; aashetty@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: December 16, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: June 1, 2017
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

GB (1)