Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Control Group - Nonoperative Subjects that were treated with a sling for their displaced midshaft clavicle fracture. |
|
| Test Group - Intramedullary Nail Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. |
Device: CRx
The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- DASH Score [One time point]
Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.
Secondary Outcome Measures
- Range of Motion and Strength [One time point]
The ASES instrument will be used to assess range of motion and strength.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A displaced transverse or oblique midshaft clavicle fracture with or without comminution
-
Must be 12 ± 2 months to 36 ± 2 months post-treatment
-
Must have received nonoperative treatment or operative treatment with a CRx™ device, no other devices, for their clavicle fracture
-
Male or female at least 18 years of age
-
Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
-
Ability to understand and provide written authorization for use and disclosure of personal health information
Exclusion Criteria:
-
Open, or segmental clavicle fracture
-
Any clavicle or upper extremity fracture previous, concurrent, or subsequent to the study fracture
-
Removal of the CRx™ device within 8 weeks of the study visit
-
History of alcoholism
-
Currently on chemotherapy or radiation therapy
-
Habitual use of narcotic pain medications prior to injury or after injury for reasons other than clavicle pain
-
Currently on worker's compensation
-
History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
-
Rheumatoid arthritis or other inflammatory arthropathies.
-
History of chronic pain issues for reasons other than clavicle pain or psychiatric disorder that precludes reliable follow-up.
-
Women that are pregnant or think that they might be pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | North Coast Orthopaedics and Sports Medicine | Arcata | California | United States | 95521 |
| 2 | Madison Center/Polyclinic | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Sonoma Orthopedic Products, Inc.
Investigators
- Principal Investigator: John LeBlanc, DO, North Coast Orthopaedics and Sports Medicine
- Principal Investigator: Carl Basamania, MD, Madison Center/Polyclinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRx-001
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control Group - Nonoperative | Test Group - Intramedullary Nail |
|---|---|---|
| Arm/Group Description | Subjects that were treated with a sling for their displaced midshaft clavicle fracture. | Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures. |
| Period Title: Overall Study | ||
| STARTED | 0 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Control Group - Nonoperative | Test Group - Intramedullary Nail | Total |
|---|---|---|---|
| Arm/Group Description | Subjects that were treated with a sling for their displaced midshaft clavicle fracture. | Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures. | Total of all reporting groups |
| Overall Participants | 0 | 0 | 0 |
| Age () [] | |||
| <=18 years | |||
| Between 18 and 65 years | |||
| >=65 years | |||
| Gender () [] | |||
| Female |
0
|
||
| Male |
0
|
||
Outcome Measures
| Title | DASH Score |
|---|---|
| Description | Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function. |
| Time Frame | One time point |
Outcome Measure Data
| Analysis Population Description |
|---|
| Terminated due to low enrollment |
| Arm/Group Title | Control Group - Nonoperative | Test Group - Intramedullary Nail |
|---|---|---|
| Arm/Group Description | Subjects that were treated with a sling for their displaced midshaft clavicle fracture. | Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures. |
| Measure Participants | 0 | 0 |
| Title | Range of Motion and Strength |
|---|---|
| Description | The ASES instrument will be used to assess range of motion and strength. |
| Time Frame | One time point |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control Group - Nonoperative | Test Group - Intramedullary Nail |
|---|---|---|
| Arm/Group Description | Subjects that were treated with a sling for their displaced midshaft clavicle fracture. | Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Control Group - Nonoperative | Test Group - Intramedullary Nail | ||
| Arm/Group Description | Subjects that were treated with a sling for their displaced midshaft clavicle fracture. | Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures. | ||
All Cause Mortality |
||||
| Control Group - Nonoperative | Test Group - Intramedullary Nail | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Control Group - Nonoperative | Test Group - Intramedullary Nail | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Control Group - Nonoperative | Test Group - Intramedullary Nail | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Rick Epstein |
|---|---|
| Organization | Sonoma Orthopedics |
| Phone | 8479872516 |
| repstein@sonomaorthopedics.com |
- CRx-001