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CompletedNCT03286270mRUSTUSUpdated Jun 11, 2020

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

An observational study in Delayed Union Fracture, CT-scan and X-Ray, sponsored by Bone Therapeutics S.A. Completed at 4 sites in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Bone Therapeutics S.A · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
173
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Delayed Union Fracture
  • CT-scan
  • X-Ray
  • Bone Fracture
  • Fracture Healing
  • Validation Studies

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Keywords

  • mRUS
  • validation tool
  • Impaired fractures
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Long bone fracture

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

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
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
173 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. mRUS assessed on X-Ray

    Time frame: 75-110 days after fracture occurrence

Secondary outcomes

  1. TUS assessed on CT-scan

    Time frame: 75-110 days after fracture occurrence

06

Study locations

4 sites
  • Investigating site DE01
    Cologne, Germany
  • Investigating site DE03
    Lübeck, Germany
  • Investigating site DE02
    Munich, Germany
  • Investigating site DE04
    Würzburg, Germany
07

Registry details

Key details

Study ID
NCT03286270
Lead sponsor
Bone Therapeutics S.A
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Sep 1, 2017
Primary completion
Apr 27, 2018
Completion
Apr 27, 2018
Last update
Jun 11, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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