Indications
INDICATIONS POSTERIOR DYNAMIC STABILIZATION
The HPS™ Hybrid Performance System as a system for posterior dynamic stabilization is intended for posterior dynamic stabilization at one to three contiguous spinal segments from L1 to S1 after (micro -) surgical decompression in the treatment of degenerative spinal stenosis including degenerative spondylolisthesis (pseudospondylisthesis) up to Meyerding grade 1, which were previously unsuccessfully conservatively treated.
POSTERIOR RIGID STABILIZATION
The HPS™ Hybrid Performance System as a posterior rigid stabilization system is intended for posterior rigid stabilization of the thoracolumbar spine as adjunct to fusion for the following indications:
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis
- Trauma (i.e., fracture or dislocation)
- Curvatures (i.e., kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- and failed previous fusion
HPS™ PEDICLE SCREW, FENESTRATED
The HPS™ Pedicle screw, fenestrated, is indicated for the use with bone cement in patients with diminished bone quality (e.g. osteoporosis, osteopenia, metastatic disease) and shall only be used with components for posterior rigid stabilization of the HPS™ Hybrid Performance System for mono – or multisegmental stabilization of the thoracic and lumbar spine for supporting fusion.
Fusion
Use of the fusion components are indicated for monosegmental or multisegemental stabilization of the thoracic and lumbar spine for supporting fusion. Fusion may be necessary due to:
- Degenerative instability
- Pseudarthrosis / delayed union
- Post-discectomy syndrome
- Spondylolisthesis
- Degenerative lumbar scoliosis
- Lumbar spinal canal stenosis
- Fracture
- Tumor
- Long idiopathic or congenital deformities
Contraindications
CONTRAINDICATIONS POSTERIOR DYNAMIC STABILIZATION
Do not use the HPS™ Rod coupler in cases of:
- Degenerative spondylolisthesis greater than grade 1 or isthmic spondylolisthesis.
- Degenerative scoliosis greater than 15 degrees.
- Dysplastic spondylolisthesis
- Fracture
- TumorInfection
- Severe instabilities
General contraindications
Generally, do not use the HPS™ Hybrid Performance System for the following conditions:
- All medical and surgical conditions that exclude the advantages of spine surgery.
- Damage to the bone structure that prevents a stable.
- implantation
- Acute or chronic systemic, spinal or localized infections.
- Impaired wound healing
- Active systemic and metabolic diseases
- Obesity (BMI ≥30)
- Fever
- Pregnancy
- Medication and substance abuse, alcoholism
- Lack of patient cooperation
- Mental illness
- Sensitivity to foreign bodies such as implant materials
- Serious osteopenia
- Osteoporosis
- Neuromuscular disorders or illnesses
- Bone tumors in the proximity of the implant fixation
- Fracture
- Other cases that are not listed among the “Indications
CONTRAINDICATIONS WITH USE OF BONE CEMENT
- Poor visualizing at Fluoroscopy
- Thrombophilia
- Patients with severe heart and/or lung failure
- Patients with known sensitiveness to elements of the bone cement.
Refer to the IFU of the bone cement supplier for further contraindications.
Safety precautions
-
- Prior to use, thoroughly read these instructions for use and become familiar with the surgical technique.
- Keep the instructions for use accessible to all staff.
- The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating techniques.
- Proper surgical performance of the implantation is the responsibility of the operating surgeon.
- The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant, incorrect operating techniques, the limitations of treatment methods or inadequate asepsis.
- Under no circumstances may modular implant components from different suppliers be combined.
- Damage to the weight-bearing structures can give rise to loosening, dislocation and migration, as well as other complications.
- To ensure the earliest possible detection of such catalysts of implant malfunction, the implant must be checked periodically post-operatively using appropriate techniques.
- Only stabilize a segment with either rod couplers or fusion components.
- Do not use both a rod coupler and a fusion component at the same level!
- Never reuse an implant. Although the implant may appear undamaged, previous stresses may have created non-visible damage that could result in implant failure.
- Never use implants if the packaging is damaged. An implant with damaged packaging might be damaged itself and thus may no longer be used.
- Never use implants that are past their expiration date.
- Each patient’s record shall document the implant used (name, article number, lot number).
- During the postoperative phase, in addition to mobility and muscle training, it is of particular importance that the physician keeps the patient well informed about post-surgical behavioral requirements.
