Treatment of the fifth metatarsal shaft fractures: a randomised controlled trial.

Conditions: fifth metatarsal shaft fractures
fractures of the lesser toe
10005944

Registration Number: NL-OMON51375

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 64

Inclusion Criteria

- 18 years or older at the time of study entry
- Informed consent
- Competent to participate in follow up and fill out questionnaires
- Dislocated (1mm or more on plain radiography) fracture of the shaft, distal
from zone 3, of the fifth metatarsal according to the Orthopedic Trauma
Association (OTA) classification 87.5.3 A-C

Exclusion Criteria

- Open fracture
- Proximal fifth metatarsal fracture, Jones fracture
- Clinically significant or symptomatic vascular or neurologic pathology on the
ipsilateral leg
- Former surgery or history of development disorder of the contralateral fifth
metatarsal
- Multiple fractured metatarsals in the affected foot
- Medical history of Rheumatoid Arthritis
- Unable to undergo surgical procedure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is difference in NRS-11 score for pain between the two<br /><br>groups at three months. This is a patient reported rating scale, resulting in a<br /><br>score ranging from 0-10 where 10 is the worst pain ever experienced. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Impact on daily living will be measured by<br /><br>* Return to work<br /><br>* Return to normal footwear<br /><br><br /><br>Impact on fracture healing will be measured by<br /><br>* Malunion of the fracture<br /><br>* Non-union of the fracture<br /><br>* Complication rate<br /><br><br /><br>Functional outcome will be measured by the questionnaires<br /><br>* FAAM<br /><br>* PROMIS<br /><br>* AOFAS LTS<br /><br>* NRS-11 measured across the different timepoints of the follow up (6<br /><br>weeks. 3, 6 and 12 months)</p><br>