A Study to Compare Two Techniques for Articular Cartilage Repair: Cultured Chondrocytes Vs. Cultured BMAC

NCT01961973 | Unknown DMC

• 1 other identifier: ShettyKimRF 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Study Title: A study to compare two articular cartilage repair techniques in the knee joint: The use of Cultured Chondrocytes Vs. Cultured bone marrow aspiration cells. 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 not be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty, who is one half of the team that devised both techniques. 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, 6 months, 1 year and 2 years following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores; cartilage growth will be measured by the MOCART score. Planned Trial Period: Two to three years Primary Objective: To establish superiority, if any, of either procedure over the other by studying pain relief, cartilage growth and improvement in function. Primary Endpoint: At the end of the 2 year follow up for all participating patients.

Conditions

The Focus of the Study is the Quality and Amount of Regenerated Articular Cartilage.

Keywords

Articular cartilage; Chondrocytes; BMAC

Outcome Measures

Primary Outcomes (2)

• Clinical outcome

  This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The superiority will be assessed with by the IKDC, KOOS, Lysholm scores measured pre- and post-operatively.

  2 years

• Radiological outcome

  This study aims to compare two techniques of articular cartilage repair in the knee, namely the use of cultured chondrocytes and the use of cultured bone marrow aspirate cells (BMAC). The principal objective of is to ascertain and assess the superiority, if any, of either surgical technique over the other. The radiological superiority will be assessed with by MOCART scores measured pre- and post-operatively.

  2 years

Study Arms (2)

Cultured chondrocytes

ACTIVE COMPARATOR

Cultured chondrocytes: This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery.

Procedure: Cultured Chondrocytes

Cultured BMAC

ACTIVE COMPARATOR

This method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee.

Procedure: Cultured BMAC

Interventions

Cultured Chondrocytes PROCEDURE

This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery.

Cultured chondrocytes

Cultured BMAC PROCEDURE

This method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee.

Cultured BMAC

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 to 65 years.
• Diagnosed with articular cartilage defect in the knee (ICRS/Outerbridge grade III/IV cartilage lesions as assessed on MRI scan).
• No other significant medical co-morbidities, as assessed by pre-operatively, that could interfere with surgery results of trial eg. Hypertension, COPD etc.
• Participant has clinically acceptable laboratory and ECG tests at pre-assessment clinic.
• Able (in the Investigators opinion) and willing to comply with all study requirements.
• Up to 3 lesions of sizes 2-8 cm2

You may not qualify if:

• Generalized and/or inflammatory arthritis
• Active joint inflammation
• More than 5 degrees of varus or valgus deformity
• Age below 18 and over 65 years
• More than 4 lesions
• Lesions more than 8 cm2
• Significant co-morbidities or classified as ASA grade 3/4

Sponsors & Collaborators

• Shetty-Kim Research Foundation: lead

Study Sites (1)

Kent Knee Unit

Walderslade, Kent, ME5 9PG, United Kingdom

Location

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 14, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

GB (1)