Trials / Terminated
TerminatedNCT01975467
Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
CLAVICLE FRACTURE OUTCOMES: 1-3 YEAR FOLLOW UP OF DISPLACED MIDSHAFT FRACTURES TREATED WITH INTRAMEDULARY NAIL vs. NONOPERATIVE TREATMENT
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 9 (actual)
- Sponsor
- Sonoma Orthopedic Products, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as compared to nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CRx | The CRx is used to treat mid-shaft, with or without comminution clavicle fractures. |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-06-01
- Completion
- 2014-06-01
- First posted
- 2013-11-04
- Last updated
- 2016-12-28
- Results posted
- 2016-12-28
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01975467. Inclusion in this directory is not an endorsement.