The SpineCorporation recibió un fondo del Departamento de Comercio e
Industria en Noviembre de 2002 para investigar nuevas tecnologías para
facilitar el uso del Sistema SpineCor.
Aunque la investigación todavía se encuentra en sus inicios, The SpineCorporation
planea producir un software que acelere la clasificación de las curvas y, por
tanto, que reduzca el tiempo necesario para colocar un corsé a un paciente.
Orthopedics Today publicó un artículo acerca de los últimos resultados del tratamiento presentados por el Dr. Charles Rivard en el Congreso.
Cobb angles worsened in 42% of unbraced and 5% of brace
patients studies.
Interim Results of the first prospective randomized study of scoliosis patients
with Cobb angles between 15º and 30º showed that the use of a dynamic back
brace helped prevent worsening of their curves.
Despite unquestionable success with the treatment - only a few of the
braced patients worsened - the study may soon be discontinued due to ethical
concerns, investigators said.
"This interim evaluation represents a strong tendency, where 42% of the
control group worsened compared to the treatment group, which showed a worsening
in only 5% of patients. These interim results, which show a large
difference in worsening between treated and untreated patients, questions the
logic of continuing this prospective randomized study." said Charles H
Rivard, MD of Ste Justine Hospital in Montreal.
Rivard presented results during the 4th Annual Meeting of the Spine Society of
Europe, here.
If scoliosis patients with Cobb angles of this size are not treated, the curves
have a 68% risk of progression, according to the literature, he said. The
dynamic brace Rivard used resulted in aesthetic outcome and patient compliance
that was better than achieved with rigid braces. "The most important
thing is to initial treatment prior to the development of bone structure
deformation," he said.
Investigators randomized 65 children with scoliosis into two
groups. For inclusion, patients had to have scoliosis curves with initial
Cobb angles between 15 and 30º and no contraindications based on a clinical
examination and AP and lateral radiographs. The Risser sign also had to be
0, 1 or 2 and there had to be a high risk of progression - a Cobb angle increase
of 5º or more in the past six months.
The control group consisted of 36 patients whose mean Cobb angles were 22º, +
or - 5º. The average age of all patients was 12 years.
Patient in the treated group received treatment with the SpineCor Brace (The
SpineCorporation Ltd: Chesterfield, England). The brace, available
worldwide since 1999, is adjustable and provides correction as the child moves
and grows. It consists of a plastic pelvic base, cotton vest, thigh bands
and four adjustable bands. Users wear the brace as much as 20 hours per
day.
During the study, three patients withdrew from each group.
For the 33 patients left in the control group, the mean Cobb angle at the last
examination was 26º + or - 8º, which meant that 45% of control patients were
stable, 12% were improved and 42% worsened. Worsening meant an increase in
Cobb angle of >5º within six months, which investigators confirmed using
radiographs.
For the 20 patients who remained in the treated group, the mean Cobb angle while
braced was 15º + or - 7º. This resulted in improvements in 76% of
treated patients, stability in 14% curve worsening in 5%. The other six
treated patients were weaned off the brace Rivard said.
In a corresponding poster session, the investigators reported the outcomes of
the initial cohort of 195 scoliosis patients treated with the SpineCor
brace. Braced patients had an initial decrease in spine curve.
Stabilization and correction lasted to the end of treatment and was maintained
for one to four years of follow-up.
Rivard, CH, Coillard C, Zabjek KF. A prospective randomized study of the natural history of idiopathic scoliosis vs. treatment with the SpineCor brace. Interim results #35. Presentado en la 4ª Reunión Anual de la Sociedad Europea de Columna (Spine Society of Europe), Sept 11-14, 2002, Nantes, Francia.