Acute, Displaced Midshaft Clavicle Fractures Clinical Trial
Official title:
Neither Operative Nor Non-operative Approach is Superior Treating Displaced Midshaft Clavicle Fractures: a Randomised Clinical Trial
NCT number | NCT01483482 |
Other study ID # | CORH-IB-0001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2011 |
Est. completion date | September 2016 |
Verified date | June 2019 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures
seen in orthopedics.
There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle
fractures. Conservative treatment has, traditionally, been the preferred treatment but recent
studies have shown higher incidences of non-union and symptomatic malunion associated with
conservative treatment. Primary surgery has in several studies been associated with high
success rates and few complications but there is no compelling evidence towards superior
results after primary surgery.
The objective of this randomized study is to compare conservative treatment (sling) with
primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.
Status | Completed |
Enrollment | 120 |
Est. completion date | September 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age 18-65 years - The patient can not have any medical untreated illness : only ASA 1-2 - The patient must be able to speak and understand Danish. - The patient must be able to give informed consent. - The patient is expected to be able to follow the postoperative controls. Exclusion Criteria: - Multitrauma patient - Other simultaneous fractures - Former surgery of the shoulder or clavicular. - Former chronic illness of the shoulder - Pathological or open fractures - Associated nerve or vessel damage of the affected arm. - Fractures older than 3 weeks (21 days) - Patients with drug(alcohol abuse where it is not expected that the patient i able to complete the follow-up. |
Country | Name | City | State |
---|---|---|---|
Denmark | University Hospital of Hvidovre | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional outcome | Constant score and DASH score is used to evaluate the functional score at 6 weeks, 6 months and 12 months. | 12 month follow-up | |
Secondary | Clinical assessment | Clinical and radiological assessment is done at 6 weeks, 6 months and 12 months of follow-up. Non-union, symptomatic manlunion,surgical complication (infection, hardware failure) is registered. | 12 month follow-up |