Comparing different flexibility rods for treating degenerative lumbar spine diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, randomized clinical study aims to evaluate the effectiveness and safety of high- or mid-flex rods compared to low-flex rods in treating degenerative lumbar spine conditions. A total of 126 participants with degenerative symptoms affecting 1 to 2 segments of the lumbar spine will be recruited and randomly assigned to receive one of three types of rods: elastic, medium, or stiff. The primary outcome will be the reduction in back pain, while secondary outcomes will assess functionality over a period of up to five years through follow-up questionnaires.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1
* signed informed consent of participant
* confirmation of the participant that the attendance of follow-up visits are intended
* Body-Mass-Index \< 32
* Pedicle screw axis distance \< 30mm
* one or more of the following indications:

  * (dynamic) stenosis in the spinal canal
  * neuroforaminal stenosis
  * facet joint syndrome / spondylarthrosis
  * discopathy (recurrent disc hernia)
  * degenerative spondylolisthesis (Meyerding \<1)
  * instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)

Exclusion Criteria:

* missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible
* damaged structural tissue, e.g. due to a bone fracture
* application to the thoracic or cervical spine
* pronounced idiopathic scoliosis
* spondylolisthesis \> Meyerding grad 1
* isthmic spondolylysis
* bone tumor
* osteochondrosis modic type I, II or III
* osteoporosis, which could impair screw anchoring
* history with third party implants
* patients with an active local or systemic infection
* known allergy to titatnium alloys
* skeleton in growth (epiphyseal joints not closed)
* severe muscular neuronal or vascular disease
* immunosuppresive therapy
* long-term therapy with cortisone
* heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics
* chronic pain patients
* incapable of judgment or emergency situation
* implantation during pregnancy

Where it's running

• Spital Aarberg
  Aarberg, Switzerland Recruiting
• Hirslanden Klinik Linde
  Biel, Switzerland Recruiting

Study contacts

• Principal investigator: Philipp Cathrein, Dr.med. — Hirslanden Klinik Linde
• Study coordinator: Sarah Abramovic
• Email: sarah.abramovic@spinesave.com
• Phone: +41448669280

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.