Debilitating low back paIn: multi-centre Safety and performanCe invEstigation Of CAdisc*-L, total disc ReplacemeNt therapy.

Low Back Pain (LBP) is an extremely complex, common and debilitating condition
with a multifactorial background of causes both physical and psychological and
as such consumes huge amounts of healthcare resources. It accounts for more
than 150 million days per annum lost to industry in UK. More than half these
days lost are related to the long term sick. The cost to the health service in
the treatment of low back pain is over £500,000,000.
It has been suggested that at least 84% of people will have at least a single
episode of LBP in their lifetime and that as many as 22-65% of all patients may
be experiencing some degree of LBP in any single 12 months period . Most
episodes of LBP resolve within a 6 weeks period of conservative and/or
pharmaceutical treatment. However, once a patient has suffered an initial back
problem nearly 70% will continue to experience recurrent episodes of LBP of
variable severity and periodicity. Between 5% and 10% of patients will suffer
from repeated protracted periods of moderate to severe LBP during their
lifetime1 with its associated impact on healthcare resources and costs. Such
patients often ultimately require surgical treatment.
Therefore Ranier Technology Ltd are conducting this study an international,
multicentre, open, clinical investigation with
comparison to preoperative data.
The study involves the surgical replacement of the lumbar intervertebral discs
(L3 to S1) for patients requiring surgical
intervention for total lumbar disc replacement for treatment of debilitating,
chronic low back pain

The objectives of this study are to evaluate the safety and performance of the
CAdisc*-L Total Lumbar Disc Replacement Device in the surgical replacement of
the lumbar intervertebral discs (L3 to S1) for patients requiring surgical
intervention for total lumbar disc replacement for the treatment of
debilitating, chronic low back pain.
Safety will be assessed by review of frequency of revision and other adverse
device events as in the context of other marketed devices as published in the
literature. Performance information will be collated from patient derived
Outcome Scores: the Oswestry Disability Index (ODI), EQ5D, Pain VAS and SF36.
Radiographic data will be gathered to demonstrate both safety and performance
of the device in terms of initial positioning, subsequent migration, implant
integrity, range of motion and correction & maintenance of disc height.
Should the safety and performance of the device be demonstrated then the
information derived from the above test will form the basis of device claims.

This is an international, multicentre, prospective, open non-randomised study
design. Patients will be included in the study after giving written informed
consent and will be subject to the routine surgical and post-operative care at
each participating centre. Additionally, local ethics and Competent Authority
approval or notice of no objection will be obtained in each centre prior to
recruitment there.
The recruitment phase is estimated as 6 months. Assessments are to be carried
out as per routine practice where possible, but will correspond to the
following schedule: pre-operative; peri-operative; and post-operatively at 6
weeks, 3 and 6 months, followed by a further assessment at 12 months and
annually thereafter to five years post-operatively, i.e. 12 & 24, 36, 48 and 60
months. The study is aimed at evaluating safety and performance for CE Marking
of the device and an interim analysis will be performed after 25 patients have
reached 3 months follow-up, but additionally, all those patients having reached
6 months or more, will also be reported.
Performance of the CAdisc*-L will be assessed using a selection of validated of
outcomes questionnaires (including Oswestry Disability Index (ODI) , SF36 v
2.0 and Euroqol (EQ5D v 1.0) & Pain Visual Analogue Scale (VAS) .
Reoperation and other adverse device events will be assessed to measure safety
. Patients will be screened preoperatively to ensure psychological factors of
condition and suitability for entry to study linked to inclusion and exclusion
criteria.

Not Applicable

Participation in the study, does not introduce any additional risk to the
patient because the study will follow normal routine practice at each hospital
in terms of surgical technique, radiographic review and follow-up visits.
However, while the risk management process takes into account many bench,
durability and non-human in vivo tests, this is the first use of the device is
man and therefore the exact safety and performance characteristics of the
device in humans are unproven, hence the reason for the trial. A potential
benefit to a patient from participation in the study is linked to data
collection, and regular review, which could identify any potential problems
earlier than would normally clinically present. Indeed there is some evidence
to suggest that participants in a trial have better outcomes than those in
routine clinical practice .
Most hospitals already collect some form of outcome score data for their
patients either in the form of SF36, GPOS or ODI so the only inconvenience for
the patients will be the need to complete two or three questionnaires instead
of one. The issue of additional burden was put to the surgical contingent of
Ranier Technology*s Scientific Advisory Board. The board held an alternative
view. Their clinical experience suggested that it should not be viewed as a
burden at all: the fact that patients are being asked for their personal
experience was in fact a highly positive and beneficial process, which
empowered the patient. The key potential benefit of this next generation
device is that it has been engineered to match closely the physiological
performance of a natural disc, more so that is the case for existing disc with
metallic components. In this way it is possible that the treatment option of a
CAdisc*-L will yield excellent outcomes and resolve the symptoms of low back
pain in trial participants.
Risk management; analysis, evaluation and control of all potential sources of
hazard and of failure modes has been conducted according to the benchmark
standard ISO 14971 and with reference to the experience of other marketed
devices (the output of which is available upon request). In summary, this
output shows that none of the reviewed Failure Modes pose an unacceptable risk
either because of the anticipated low probability of occurrence or because any
problems resulting from failure would generally be considered of low risk to
the patient when weighed against the potential benefits, described above.
However, as is the case with all spinal implants, it is possible that the
implant will not completely relieve all patients* low back pain.
Subjects will be advised of the potential risks and benefits associated with
this investigation in the Patient Information Sheet which will be approved by
the local Research Ethics Committee, prior to enrolment.