Status:
COMPLETED
A mRUS Validation Study for Nail-treated Fractures of Long Bones and a TUS Exploratory Study for Nail and Plate-treated Fractures of Long Bones
Lead Sponsor:
Bone Therapeutics S.A
Conditions:
Delayed Union Fracture
CT-scan
Eligibility:
All Genders
18-80 years
Brief Summary
Early intervention attempts to shorten protracted delayed union (DU) or prevent non-union (NU) fractures are hampered by lack of validated quantitative assessment tools for bone fracture healing durin...
Eligibility Criteria
Inclusion
- Male or female adult patient (\>18 and \< 80 years old)
- Patient with nail(s) (for mRUS validation study and TUS exploratory study) or plate(s) (for TUS exploratory study) treated long bone fractures, corresponding to the following OA/OTA classification: 11-A, 12-A, -B and -C, 13-A, 21-A, 22-A, -B and -C, , 31-A3, 32-A, -B and -C, 33-A 41-A2 and A3, 42-A, -B and -C and 43-A
- Patient for whom outcome of fracture is known
- For the mRUS validation study, patient with one follow up X-ray imaging performed 75-110 days after fracture occurrence
- For the TUS exploratory study, patient with one follow up CT-scan imaging performed 75-110 days after the fracture occurrence
Exclusion
- Bone infection diagnosed between time of the fracture occurrence and the X-Ray or CT-scan imaging performed 75-110 days after the fracture occurrence
- Previous fracture and previous surgery on the fractured bone
- Bone tumour or history of bone tumour
- Bone metastasis
- Known evidence for ongoing metabolic bone disease (e.g. chronic renal failure, hyper or hypoparathyroidism, rickets, Paget's disease of bone, inherited or congenital bone abnormalities)
- Patient with current traumatic brain injury
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 27 2018
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT03286270
Start Date
September 1 2017
End Date
April 27 2018
Last Update
June 11 2020
Active Locations (4)
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1
Investigating site DE01
Cologne, Germany
2
Investigating site DE03
Lübeck, Germany
3
Investigating site DE02
Munich, Germany
4
Investigating site DE04
Würzburg, Germany