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

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.

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Key information

Conditions

Delayed Union Fracture Bone Fracture CT-scan Fracture Healing Fractures, Bone Validation Studies Wounds and Injuries X-Ray

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigating site DE01, Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

mRUS assessed on X-Ray

Time frame: 75-110 days after fracture occurrence

Secondary outcomes

TUS assessed on CT-scan

Time frame: 75-110 days after fracture occurrence

Sponsors and collaborators

Lead sponsor

Bone Therapeutics S.A

Industry

Registry information

Acronym: mRUSTUS

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Sep 18, 2017
Registry last updated: Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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