WHO ICTRP trial
Clinical outcome and fusion rates after surgery with TM Ardis interbody fusion…
ISRCTN89404187 · International Standard Randomised Controlled Trial Number (ISRCTN) · Not Recruiting
Key facts
| Trial ID | ISRCTN89404187 |
|---|---|
| Public title | Clinical outcome and fusion rates after surgery with TM Ardis interbody fusion system |
| Scientific title | A prospective, multi-center, post-market surveillance study to assess the clinical efficacy and fusion rates of the Zimmer®TM Ardis Interbody Fusion System |
| Primary sponsor | Zimmer Spine (France) |
| Registry | International Standard Randomised Controlled Trial Number (ISRCTN) |
| Recruitment status | Not Recruiting |
| Study type | Observational |
| Phase | Phase IV |
| Countries | Belgium;Germany;Spain;Sweden;United Kingdom |
| Conditions | Degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis Musculoskeletal Diseases Spondylolisthesis |
| Interventions | Lumbar surgery: Over a period of two years participants will be followed on a regular basis (3, 6, 12 and 24 months) to assess clinical outcomes and radiological parameters. Patients will be asked to answer to quality of life questionnaires… |
| Registration date | Jan 27, 2014 |
| Target size | 80 |
| Secondary IDs | NCT02429908;CME2013-01S |
| Registry page | isrctn.com |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: