Trials / Terminated
TerminatedNCT02560714
SI Joint Fusion and Decortication Using the SImmetry System
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 17 (actual)
- Sponsor
- Zyga Technology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief of SI joint pain symptoms.
Detailed description
This is a prospective, non-randomized post market study designed to collect data on SI joint fusion and subject back pain following implant of the SImmetry device. The study will be conducted at a single site and 25 subjects will be implanted and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SImmetry Sacroiliac Fusion System | SImmetry The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, providing stability for intra-articular fusion. The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion. |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2017-12-01
- Completion
- 2017-12-01
- First posted
- 2015-09-25
- Last updated
- 2017-12-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02560714. Inclusion in this directory is not an endorsement.