Study will measure performance of synthetic bone graft substitute in 30 patients undergoing spinal fusion for degenerative disc disease
ApaTech, a private orthopaedics company specialising in synthetic bone graft substitutes, has announced the start of a first prospective study of its lead product, ApaPore, in 30 patients undergoing spinal fusion for degenerative disc disease.
The study will compare the performance of ApaPore mixed with bone marrow aspirate when used with or without the addition of 50% autologous bone graft.
Routine instrumented posterolateral surgery will be performed in all cases and the patients randomised to the two different materials combinations to allow for blinded independent radiographic assessment.
The purpose of the study, which is taking place at Woodend Hospital, Aberdeen, is to measure the performance of ApaPore and any clinical or mechanical post-operative complications that occur, and any revisions or re-operations required.
The study will also assess the patients' subsequent quality of life, by means of routine outcome measures for back pain.
Performance will be measured against existing data from matched groups of patients who have undergone instrumented posterolateral surgery with: two other bone graft substitutes mixed with autograft, autograft alone and allograft.
Patients will be reviewed routinely at 3, 6, 12, and 24 months, by assessing clinical outcomes and radiographs. "This first study will test whether bone growth is achieved in spinal fusions which are conducted without autograft, using only ApaPore with bone marrow aspirate.
As autograft is used in the majority of these operations, the results of this study will be important both for ApaPore, and for patient outcomes and quality of life", said Peter Lawes, ApaTech's CEO. ApaTech, 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, 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 and 3i Bioscience Investment Trust.
