Lumbar or Thoraco-lumbar Adult Deformity Clinical Trial
Official title:
The Relationship Between Sagittal Plane Correction and Quality of Life in Adult Deformity Patients Treated With Posterior Instrumentation
| Verified date | March 2017 |
| Source | Medicrea International |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility |
Inclusion criteria - Lumbar or thoraco-lumbar Adult Deformity requiring posterior spinal instrumentation and fusion like: - Scoliosis - Kyphosis - Kyphoscoliosis - Patient with a Cobb angle = 30° and/or confirmed sagittal imbalance defined as sagittal vertical axis (SVA) more or equal to 5cm and/or a loss of lumbar lordosis versus the pelvic incidence - Patient = 21 years old - Surgery that requires 4 or more levels to be operated - Patient with complete pre-operative radiographic data: antero-posterior and lateral standing full spine x-rays (from hips to C2) and lateral bending x-rays (standing) - Patient able to complete a self-administered questionnaire - Patient able to sign a consent form Exclusion criteria - Patient operated with posterior spinal fusion without PASS LP device - Patients who required a Vertebral Column Resection technique surgery - Neuromuscular scoliosis or diseases and any neuro-related pathology - Spinal cord abnormalities with any neurologic symptoms or signs - Primary abnormalities of bones (e.g. osteogenesis imperfecta) - Recent significant trauma - Patient is involved in current medical litigation - Metabolic spinal pathology - Pathologic obesity (BMI > 40) - Patients with infection (in particularly osteomyelitis) - Patient < 21 years old - Pregnancy or intended to get pregnant during the next 3 years - Insulin-dependent diabetes - All other contra-indications given in the PASS® LP System instructions for use - Patient unable to sign an informed consent form - Patient unable to complete a self-administered questionnaire |
| Country | Name | City | State |
|---|---|---|---|
| France | Santy orthopedic center | Lyon | |
| United States | UC Denver | Denver | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Medicrea International |
United States, France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation between correction of SVA and improvement ODI | The primary objective is to evaluate the correlation between: the correction of the Sagittal Vertical Alignement (SVA), expressed in centimeters - SVA is the distance between C7 plumbline and the posterior of the superior endplate of S1) the improvement of the Oswestry Disability Index (ODI) is the positive difference of the preoperative score and the postoperative score - expressed in % or a score (/50) |
preop, 3 months, 6 months, 12 months, 24 months | |
| Secondary | Correction of the sagittal parameters | Sagittal parameters are evaluated by: - Cobb angle: Thoracic kyphosis measured from T5 to T12 and between the 2 inflexion points of the curve Lumbar lordosis measured from T12 to S1 and between the 2 inflexion points of the curve Pelvic Incidence (PI) Pelvic Tilt (PT) Sacral Slope (SS) Proximal junction Cobb angle T1 spinopelvic inclination (T1-SPI) |
preop, 24 months | |
| Secondary | improvement of Quality of life | The effect that the patient's pathology has on his/her daily life evaluated by the Scoliosis Research Society (SRS-22) questionnaire designed and recommended by the Scoliosis Research Society Pain reduction for back and leg by the Visual Analogue Scale (VAS) Patient satisfaction with the results of their operation using a simple questionnaire (Patient Satisfaction Index - PSI) which was designed and recommended by the North American Spine Society (NASS) |
preop, 3 months, 6 months, 12 months, 24 months | |
| Secondary | Complications associated with the device | Per and Post-operative device complications: Screw pull-out Loosening, breakage and pseudarthrosis based on x-rays analysis |
preop, 3 months, 6 months, 12 months, 24 months | |
| Secondary | Complications associated with the surgery | Peri-operative data: length of operative time, length of correction time, blood loss … Surgical complications | preop, 3 months, 6 months, 12 months, 24 months | |
| Secondary | Coronal correction | A pre/post-operative comparison of regular Cobb angles A pre/post-operative comparison of C7 plumb line (Coronal balance) A pre/post-operative comparison of Apical Vertebra Translation (AVT) |
preop, 3 months, 6 months, 12 months, 24 months | |
| Secondary | Vertebra rotation | A pre/post-operative comparison of Rotary Vertebra Subluxation (olisthesis) A pre/post-operative comparison of Apical Vertebra Rotation (AVR) - Nash Moe |
preop, 24 months | |
| Secondary | Adjacent levels degeneration | preoperative and post-operative comparison of the disc height of the upper and lower adjacent levels | preop, 24 months | |
| Secondary | Fusion | standing X-Rays observations (osseous formation) | preop, 24 months |