Synthetic
Bone Graft To Be Tested In Revision Hip Surgery
ApaPore® Impaction Grafting Hip Study Starts Patient
Recruitment
London
9th April, 2003
- ApaTech Limited, a private orthopaedics company specialising in
synthetic bone graft substitutes, announced today that it has commenced
recruitment of 300 patients for a multi-centre study* of ApaPore in
femoral and acetabular impaction grafting following failed total hip
arthroplasty.
The
purpose of this study is to evaluate the clinical outcome of the use of
ApaPore synthetic bone graft in impaction grafting in femoral and
acetabular component revision following failed total hip arthroplasty. The
outcomes to be measured are the performance of ApaPore demonstrated by
clinical and radiographic results; safety as evidenced by the incidence
and nature of any clinical or mechanical post-operative complications and
any revisions or re-operations required; and the effect on patient quality
of life by assessing range of motion, pain and activities of daily living.
The
prospective randomised multicentre study, which is being led by surgeons
at the Princess Elizabeth Orthopaedic Centre, Exeter, involves 10 surgeons
in 7 UK centres. It is
planned to recruit 300 patients
Patients
will undergo revision of their femoral and/or acetabular component with
impaction grafting. The study will compare patients undergoing impaction grafting
with allograft alone versus patients undergoing impaction grafting with a
50:50 mix of allograft and ApaPore synthetic bone graft
“This
first study of ApaPore in hip revision surgery with impaction grafting,
will confirm the safety of ApaPore in this surgical application. The use of ApaPore in impaction grafting will help surgeons
address the issues of disease transmission and the limited supply of
allograft, allowing them to continue using a successful technique in
revising failed primary total hips.” said Peter Lawes, ApaTech’s CEO.
Orthopaedic
surgeons are performing bone grafting procedures ever more frequently.
Surgical applications include treating bone defects, fracture
fixation, spinal fusion and the revision of failed total joint
arthroplasties. In Europe the
number of grafting procedures was reported to be 287,300 in the year 2000,
with a predicted increase to 479,079 in the year 2005.
The
most common source of bone graft used to be autograft, the transfer of a
small piece of the patient’s own bone from one site, usually the iliac
crest, to another. However,
the amount that can be harvested safely is limited, it increases surgery
time and may be complicated by donor site morbidity. The use of allograft, supplying bone graft from other
patients via bone banks, overcomes these difficulties.
However, the demand for allograft now exceeds the supply, there is
no assurance of freedom from disease and it is highly variable in
strength.
In
revision arthroplasty surgeons are often challenged by significant bone
loss. Impaction of cancellous
allograft with cement for revision total hip arthroplasty has proved to be
successful and is now a recognised technique. These factors have led to
increasing interest in the use of synthetic bone graft substitutes
ApaTech
Limited, based
in London, England,
is
a private orthopaedics company founded in 2001, specialising in bone graft
substitutes.
Research and IP from London and Cambridge Universities has resulted
in a unique approach to bone healing and the company retains pipeline
agreements with founding inventors, including Prof Bill Bonfield, CBE and
Queen Mary University of London.
Its
lead product, CE marked, ApaPore, is in use in patients and selling to
hospitals. It is cleared for use in all orthopaedic applications, but is
initially being used as a bone graft material in spinal fusions, bone
tumours, fractures and in the replacement of failed or loose joint
prostheses. It is a synthetic phase-pure hydroxyapatite (HA) with
consistent micro- and macroporosity and interconnectivity that maximises
favourable bone repair. Development
products, using carbonate or silicate substitution of the phosphate ions
in the HA structure, address other specific surgical requirements in neuro
and plastic as well as orthopaedic procedures.
In July 2001 the company raised £3 million in a series A private
equity financing wholly from 3i Group plc and 3i Bioscience Investment
Trust plc.
*ApaPore
Clinical Outcomes Study in Femoral and Acetabular Component Revision with
Impaction Grafting following Failed Total Hip Arthroplasty.
