Bone Fracture Clinical Trial
— mRUSTUSOfficial title:
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
NCT number | NCT03286270 |
Other study ID # | 002A/BT |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | April 27, 2018 |
Verified date | June 2020 |
Source | Bone Therapeutics S.A |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 during normal and delayed healing processes. In actual practice, sequential
X-rays usually follow a pre-determined time interval in patients with fractures.They
constitute the best available state of the art used by surgeons to assess the fracture
healing course.
In an attempt to improve between raters reliability of radiographic assessment of healing,
studies have explored a novel radiographic assessment for tibial shaft fractures, the
Radiographic Union Scale for Tibial Fractures (RUST). The RUST assesses the presence of
bridging callus and a fracture line on each of four cortices (seen on anterior-posterior and
lateral views). This callus based scoring system has been since extended to other bones than
the tibia in a retrospective case series. It has been renamed modified radiological union
score (mRUS) and has shown potential value in bone healing measurement.
Based on an initial retrospective study in nail-treated fractures, the first objective of the
present investigation is to prospectively validate mRUS as a tool to identify patients at
increased risk of DU and NU within the first 75-110 days after fracture occurrence. This
prospective validation will be performed on a retrospective cohort of patients having
sustained long bone fractures, including both upper and lower extremities. A further
objective of the present investigation is to apply the scoring system to tomographic imaging
in case of nail/plate treated fractures, deriving a tomographic union score (TUS) and first
assess its potential value in bone healing for fractures treated by nails/plates.
Status | Completed |
Enrollment | 173 |
Est. completion date | April 27, 2018 |
Est. primary completion date | April 27, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Investigating site DE01 | Cologne | |
Germany | Investigating site DE03 | Lübeck | |
Germany | Investigating site DE02 | Munich | |
Germany | Investigating site DE04 | Würzburg |
Lead Sponsor | Collaborator |
---|---|
Bone Therapeutics S.A |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mRUS assessed on X-Ray | 75-110 days after fracture occurrence | ||
Secondary | TUS assessed on CT-scan | 75-110 days after fracture occurrence |
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