Closed Fracture of Shaft of Clavicle Clinical Trial
Official title:
Functional Outcome in Midshaft Clavicle Fracture Patients, Treated With Superior Versus Anteroinferior Reconstruction Plate. Randomized Clinical Trial.
| NCT number | NCT03533634 |
| Other study ID # | UMAE |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 1, 2015 |
| Est. completion date | January 15, 2018 |
| Verified date | May 2018 |
| Source | UMAE Hospital de Traumatologia y Ortopedia de Puebla |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | January 15, 2018 |
| Est. primary completion date | September 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - traumatic fracture - ao 15 b1 and 15 b2 - no previous shoulder lesions - no further 7 days fractures - closed fracture Exclusion Criteria: - calcium diseases - Previous shoulder pain - other fractures associated |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| UMAE Hospital de Traumatologia y Ortopedia de Puebla |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disabilities of Arm Shoulder and Hand score (DASH) | we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability | 30 days after surgery | |
| Primary | Disabilities of Arm Shoulder and Hand score (DASH) | we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability | 60 days after surgery | |
| Primary | Disabilities of Arm Shoulder and Hand score (DASH) | we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability | 90 days after surgery | |
| Primary | Disabilities of Arm Shoulder and Hand score (DASH) | we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability | 365 days after surgery | |
| Secondary | Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 30 days after surgery | |
| Secondary | Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 60 days after surgery | |
| Secondary | Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 90 days after surgery | |
| Secondary | Visual Analogue Scale score (VAS) | we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain | 365 days after surgery |