Clinical trial NCT03286270: 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Union Fracture
CT-scan
X-Ray
Bone Fracture
Fracture Healing
Validation Studies
Keywords: mRUS
validation tool
Impaired fractures
Lead sponsor: Bone Therapeutics S.A
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Long bone fracture

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: mRUS assessed on X-Ray
timeFrame: 75-110 days after fracture occurrence
Secondary outcomes:
measure: TUS assessed on CT-scan
timeFrame: 75-110 days after fracture occurrence
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Investigating site DE01
city: Lübeck
country: Germany
facility: Investigating site DE03
city: Munich
country: Germany
facility: Investigating site DE02
city: Würzburg
country: Germany
facility: Investigating site DE04
Study officials:
References: