Clinical and surgical parameters can be combined to predict how long it will take a tibia fracture to heal
| ISRCTN | ISRCTN10831351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10831351 |
| Secondary identifying numbers | The FRACTING study |
- Submission date
- 29/06/2017
- Registration date
- 30/06/2017
- Last edited
- 26/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Healing of tibia (the large bone in the leg) fractures occurs over a wide time range, from a minimum of two months to a maximum of six months in most patients. In a significant percentage of patients, healing may take place well beyond six months after the trauma or may require one or more surgical procedures, with significant associated health costs. Although general and local conditions that may adversely affect fracture healing have been identified, the ability to early recognise fractures at risk of developing a non-union (failure of healing) is still left to the surgeon’s experience. The FRACTING score has been developed by using data about clinical data that is used to predict the risk of a bone to non-union. This score can be used to predict how long is needed for healing. This score may be able to identify patients who are at risk of non-union and this can allow them to pursue different treatments, resulting in reduced disability time and health cost savings. The aim of this study is to investigate the capability of the FRACTING score, calculated soon after fracture treatment to predict fracture healing time.
Who can participate?
Adults aged 18 and older who have a fracture.
What does the study involve?
Participants are suffered a tibia fracture receive their routine treatment and follow up care. During their follow up, clinical data about their healing is collected in a dedicated software and a score is used to calculate their risk of failure to healing.
What are the possible benefits and risks of participating?
Participants may benefit from knowing their score in order to receive customized treatment protocols by planning closer surveillance and specific rehabilitation. There are no risks with participating.
Where is the study run from?
This study is being run by IGEA SpA (Italy) and takes place in 40 Orthopaedic Traumatology centres (Italy).
When is the study starting and how long is it expected to run for?
January 2009 to October 2014
Who is funding the study?
IGEA SpA (Italy)
Who is the main contact?
Dr Stefania Setti
s.setti@igeamedical.com
Contact information
Scientific
IGEA SpA
Via Parmenide 10/A
Carpi (Mo)
41012
Italy
 ORCID ID |
0000-0001-8990-5452 |
|---|---|
| Phone | +39 059 699 600 |
| s.setti@igeamedical.com |
Study information
| Study design | This prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | The FRACTING (tibia FRACTure prediction healING days) Study: Can clinical and surgical parameters be combined to predict how long it will take a tibia fracture to heal? A prospective multicentre observational study |
| Study acronym | The FRACTING study |
| Study objectives | Healing of tibia fractures occurs over a wide time range (2 to >12 months) with a number of general and local factors contributing to prolonged healing. The aim of this study is to investigate the capability of the FRACTING score, calculated soon after fracture treatment to predict fracture healing time. |
| Ethics approval(s) | Ethical Committee University of Ferrara Italy, 29/09/2011 |
| Health condition(s) or problem(s) studied | Patients who had suffered a tibia fracture. |
| Intervention | Patients who had suffered a tibia fracture were recruited in 40 Italian orthopaedic traumatology centres to be surgically treated. The patient's treatment and the time of follow-up were left to the choice of the trauma surgeon based on experience. During the follow-up, clinical data about the healing is collected in a dedicated software and used to calculate the score to identify fractures at risk of non-union. Drop down menu was used for descriptive variables. Required fields ensured complete and consistent data collection.The score is calculated adding all values. Information on patient health, fracture morphology and surgical treatment adopted was combined to calculate the FRACTING score. Fractures were considered healed when the patient was able to fully weight-bear without pain. Within 12 months from trauma, the date at which the fracture healed was used to calculate days and months elapsed since treatment (“healing time”). |
| Intervention type | Other |
| Primary outcome measure | Time to healing of a tibia fracture is calculated by correlating surgical and clinical data in a dedicated software used to calculate the score: score versus healing time. |
| Secondary outcome measures | Ability of the score to identify fractures at risk of non-union healing after more than six months. |
| Overall study start date | 12/01/2009 |
| Completion date | 24/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 519 |
| Total final enrolment | 363 |
| Key inclusion criteria | 1. Patients with post-traumatic fractures type 41-A and B, 42-A-B and C, 43-A and B according to AO classification 2. Fracture treatment within 3 days from trauma 3. Patient age >18 years |
| Key exclusion criteria | 1. Fractures involving the tibia plateau and malleolar fractures 2. Patients with autoimmune diseases or neoplasia 3. Patients who could not return to the treating centre for follow-up visits |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- Italy
Study participating centre
Italy
Sponsor information
Industry
Via Parmenide 10/A
Carpi (Mo)
41012
Italy
| Phone | +39 059 699 600 |
|---|---|
| s.setti@igeamedical.com | |
| Website | http://www.igeamedical.com/about-us/innovation-over-thirty-years |
"ROR" |
https://ror.org/01bws2668 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Francesca De Terlizzi at f.deterlizzi@igeamedical.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/04/2018 | 26/11/2021 | Yes | No |
Editorial Notes
26/11/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
