NCT01076673

Brief Summary

The purpose of this study was to compare histologic and MRI evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2009

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

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

February 24, 2010

Last Update Submit

March 12, 2015

Conditions

Articular Cartilage Disorder of Knee

Outcome Measures

Primary Outcomes (1)

  • Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies

    18 months

Secondary Outcomes (1)

  • Improved long term functional outcome of subchondral drilling surgery in the knee joint

    18 months

Study Arms (2)

PBSC and Hyaluronic Acid

EXPERIMENTAL

Peripheral blood stem cells and hyaluronic acid injections

Biological: Peripheral blood stem cells and hyaluronic acid injections

Hyaluronic Acid

ACTIVE COMPARATOR

Hyaluronic Acid

Drug: Hyaluronic Acid

Interventions

Peripheral blood stem cells and hyaluronic acid injectionsBIOLOGICAL

Peripheral blood stem cells and hyaluronic acid injections

Also known as: PBSC and HA
PBSC and Hyaluronic Acid
Hyaluronic AcidDRUG

Hyaluronic acid injections

Also known as: HA
Hyaluronic Acid

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who have signed informed consent form
  • Patients with only unilateral isolated or multiple knee articular cartilage lesions demonstrated MRI scanning, with up to one previous operation on that knee
  • Patients who are either male or female aged between 18 to 50 years old, corresponding to availability of normative International Knee Documentation Committee (IKDC) data.
  • Female patients of childbearing age must have negative pregnancy tests and are advised to take contraceptive precautions throughout the study.

You may not qualify if:

  • Patients with bilateral knee lesions
  • Patients with the presence of ligamentous injury which would require reconstruction, varus or valgus deformity greater than 10 degrees, previous open total menisectomy requiring osteotomy, and cases that require complex surgery prior to cartilage regeneration
  • Patients with significant cognitive impairment, non-ambulatory status or lower extremities amputation other than toes, serious illness or medication affecting operative risk or wound healing (e.g. steroid intake, anticoagulation), and poorly controlled diabetes mellitus with a baseline HbA1c more than 8
  • Patients with significant peripheral vascular disease as indicated by absent dorsalis pedis or posterior tibial pulses.
  • Patients who cannot read English will be excluded from the study as they will be unable to complete the study questionnaires in an objective manner
  • Female patients who are pregnant
  • Patients with any contradictions to MRI scanning
  • Patients with body mass index (BMI) of over 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuala Lumpur Sports Medicine Centre

Kuala Lumpur, Malaysia

Location

Related Publications (1)

  • Saw KY, Anz A, Siew-Yoke Jee C, Merican S, Ching-Soong Ng R, Roohi SA, Ragavanaidu K. Articular cartilage regeneration with autologous peripheral blood stem cells versus hyaluronic acid: a randomized controlled trial. Arthroscopy. 2013 Apr;29(4):684-94. doi: 10.1016/j.arthro.2012.12.008. Epub 2013 Feb 4.

    PMID: 23380230RESULT

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Khay-Yong Saw, Dr.

    Kuala Lumpur Sports Medicine Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Orthopaedic Surgeon

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 26, 2010

Study Start

October 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

MY(1)