Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
Status: | Enrolling by invitation |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 2/21/2018 |
Start Date: | October 2003 |
End Date: | December 2019 |
A Multicenter, Prospective, Randomized Trial of Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder.
Some surgeons suggest that surgical treatment is the best option, while others suggest that
nonoperative care is the best treatment. There is no evidence to date that either option in
superior. For this reason, we propose to conduct a prospective, randomized clinical trial of
surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This
study will use both objective clinical and patient-based outcome measures. The purpose of
this study is to see if there is a difference between clinical outcomes (healing rate, time
to healing, time to return to work, Constant Score, complications), functional outcomes (DASH
Score), and health related quality of life (SF-36) in nonoperative care and two types of
surgical care for displaced fractures of the clavicular shaft in adults.
Included patients will be randomized into one of three groups: nonoperative care (Group N);
surgical care using plates and screws (Group P); and surgical care using intramedullary pin
put inside of the clavicle to stabilize it (Group I).
Some surgeons suggest that surgical treatment is the best option, while others suggest that
nonoperative care is the best treatment. There is no evidence to date that either option in
superior. For this reason, we propose to conduct a prospective, randomized clinical trial of
surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This
study will use both objective clinical and patient-based outcome measures. The purpose of
this study is to see if there is a difference between clinical outcomes (healing rate, time
to healing, time to return to work, Constant Score, complications), functional outcomes (DASH
Score), and health related quality of life (SF-36) in nonoperative care and two types of
surgical care for displaced fractures of the clavicular shaft in adults.
Included patients will be randomized into one of three groups: nonoperative care (Group N);
surgical care using plates and screws (Group P); and surgical care using intramedullary pin
put inside of the clavicle to stabilize it (Group I).
Inclusion Criteria:
- ages of 18 and 85
- a midshaft clavicle fracture
- fracture displaced the width of the clavicle or shortened at least 1.5 cm
- less than 21 days since the injury
Exclusion Criteria:
- injury involving the lateral ligaments
- fracture involve the sternoclavicular joint
- Pathologic Fracture
- Open Fracture
- Fracture with neurovascular compromise
- Displaced fracture with impending skin compromise
- Medical comorbidities that preclude surgery
- Associated injuries to ipsilateral shoulder girdle
- severe cognitive disability or injury that may inhibit study form completion
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