Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities

NCT06098157 | Recruiting

• 1 other identifier: TRUFFLE
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

TRUFFLE is a register of clinical patient data of failed bone healing and bone non-union after fracture. All patients suffering from a long bone delayed or non-union after fracture and undergoing revision surgery are registered with their clinical data, comorbidities, medication, soft tissue status, radiographic status, Non-Union Scoring System (NUSS) Score and are followed up until final bone healing or end of treatment. The register consists of more than 800 patients cases. The aim is to identify risk factors for healing of non-unions. Data analysis will compare those patients that undergo regular healing to those of insufficient healing.

Conditions

Pseudarthrosis; Ununited Fracture

Keywords

bone; non-union; delayed union; delayed bone healing; pseudarthrosis; callus formation; ununited fracture; fracture healing

Outcome Measures

Primary Outcomes (2)

• number of participants with successful bone healing

  End of treatment can either be successful healing or treatment with no success in bone healing (i.e. amputation, total joint replacement). The number of participants reaching successful healing (responders) to those who are not reaching successful healing (non-responders) will be analyzed.

  minimum of 1 year up to 5 years after non-union index procedure

• Time to heal

  Time to heal is defined as the length of time from non-union index procedure to date of last follow-up visit that stated radiographic and clinical success or unsuccessful bone healing (i.e. amputation, total joint replacement).

  minimum of 1 year up to 5 years after non-union index procedure

Secondary Outcomes (8)

• Charlson Comorbidity Index

  minimum of 1 year up to 5 years after non-union index procedure

• number of medication

  minimum of 1 year up to 5 years after non-union index procedure

• number of participants undergoing type of revision surgery

  minimum of 1 year up to 5 years after non-union index procedure

• number of participants suffering from local infection

  minimum of 1 year up to 5 years after non-union index procedure

• NUSS - non union scoring system

  minimum of 1 year up to 5 years after non-union index procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for delayed bone healing or non-union in a level 1 hospital of maximum trauma care

You may qualify if:

• age \>18 years
• presence of long bone non-union that required surgical treatment.
• radiological signs according to the criteria of the Radiographic Union Scale of Tibial fractures (RUST).
• clinical signs as pain, lack of weight bearing and/or limitation on range of motion.

You may not qualify if:

• age \<18 years
• Patients with non surgical intervention and presence of long bone non-union
• bone non-union that resulted from elective orthopedic surgery (e.g. osteotomies).

Sponsors & Collaborators

• Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu: lead

Study Sites (1)

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Pseudarthrosis; Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Marie K Reumann, MD

  Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen

  STUDY DIRECTOR

Central Study Contacts

Marie K Reumann, MD

CONTACT

+497071606; mreumann@bgu-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Clinical Trauma Research

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 24, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 30, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)