Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures
This study is enrolling participants by invitation only.
Sponsor:
University of Utah
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01405703
First received: July 27, 2011
Last updated: November 2, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. This study includes questionnaires and measurements that will collect data on incision-related numbness, union rates, overall outcomes, complication rates of the two methods, infection rates, and overall satisfaction. The surgical procedure, all radiographs and follow-up visits to a minimum of one year are the PI's standard of care for this injury. Measurements and questionnaires are related to the study.
| Condition | Intervention |
|---|---|
|
Clavicle Fracture |
Other: xrays |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by University of Utah:
Primary Outcome Measures:
- Functional outcome as measured by Constant Shoulder Score and DASH score [ Time Frame: 1+ year post-op ] [ Designated as safety issue: No ]The primary outcome measure for this study will be incision related numbness, based on clinical examination and the use of our skin numbness map. Our null hypothesis is that there will be no difference in incision related numbness between the two groups: percutaneous versus open approach. Our primary objective is to disprove this hypothesis, predicting that the percutaneously treated group will have less incisional numbness.
Secondary Outcome Measures:
- Incision numbness at surgical site. [ Time Frame: 2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op ] [ Designated as safety issue: No ]Our secondary outcome measures will be union, malunion, and nonunion rates between these two methods, as well as infection rates and functional and satisfaction outcomes based on subjective questioning and the DASH and Constant shoulder score questionnaires. Our null hypothesis for these secondary outcomes is that there will be no difference between the two treatment groups.
| Estimated Enrollment: | 37 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
percuataneous plate fixation
an approach with three small longitudinal incisions
|
Other: xrays
xrays from 2 week postop to 5 year postop
|
|
open plate fixation
large transverse incision
|
Other: xrays
xrays from 2 week postop to 5 year postop
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients treated surgically for diaphysial clavicle fracture.
Criteria
Inclusion Criteria:
- 18 years of age or older
- displaced (i.e., no cortical contact of fracture ends on two xray view) diaphyseal clavicle fracture
- fracture pattern amenable to plate fixation
- neurologic injury requiring open reduction
- open clavicle fracture
- clavicle nonunion (defined as an absence of radiographic bony union in the presence of neurologic, cosmetic, or functional complaints at six months duration
- symptomatic malunion (defined as a healed, but shortened or angulated fracture in the presence of neurologic, cosmetic, or functional complaints)
- clavicle fracture associated with a scapular of humeral fracture (floating shoulder)
Exclusion Criteria:
- a nondisplaced or minimally displaced closed, neurovascularly intact clavicle fracture
- fracture of the medial or lateral end of the clavicle
- pathological fracture
- patient is unable to medically tolerate general anesthesia
- patient is unable to provide informed consent or comply with completing questionnaires
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405703
Locations
| United States, Utah | |
| University of Utah Orthopedic Center | |
| Salt Lake City, Utah, United States, 84121 | |
Sponsors and Collaborators
University of Utah
Investigators
| Principal Investigator: | Erik Kubiak, MD | University of Utah |
| Principal Investigator: | Thomas chrisitensen, MD | University of Utah |
More Information
No publications provided
| Responsible Party: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT01405703 History of Changes |
| Other Study ID Numbers: | 36814 |
| Study First Received: | July 27, 2011 |
| Last Updated: | November 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
Clavicle Fractures Numbness Percutaneous plate fixation open plate fixation incision related numbness |
union rates subjective questionnaire based outcomes Diaphyseal |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013