Clinical trial NCT04112992: An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects
Official title: An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Limb Fracture
Bone Loss
Keywords: long bone defect
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a traumatic bone defect in any long bone

Brief summary: Long bone defect (LBD) is defined as a focalized loss of bone tissue in any long bone of the upper or lower extremity. Long bone defects are a complex problem, that may arise as a complication of many different pathologies, such as trauma, tumors or infection. Whereas post-traumatic defects are the largest group.

Reports estimate that there are almost 4 million bone grafting procedures worldwide per year. However, limb reconstruction in the context of a bony defect is challenging and up to date there is little evidence and treatment recommendations.

In a multi-national approach, the aim of this project is to set up an international, multicenter registry to gather information and details on prevalence or incidence, current treatments, complications and outcome.

Detailed description: The purpose of this project is to set up an international, multicenter registry of patient presenting with defects in long bones. Up to date, treatment remains challenging with little evidenced-based recommendations.

For this purpose, any patient who presents at a study center with a bone defect of the defined expansion of any long bone is eligible for inclusion. Over a 3-year period as many patients as possible are included from the participating sites, at least 600 patients should be included in the registry. Details on any surgical intervention that is used to treat a bone defect will be recorded. Further patient-related and other pre-defined outcome measures will be collected.

There is no formal hypothesis to this registry, hence it will help to identify prevalence and underlying etiologies, evaluate treatment strategies, and highlight possible challenges and complications - and will so help to gather clinical evidence to provide better treatment for patients suffering from a long bone defect.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Skeletally mature
* Post traumatic bone defect \> 2 cm either

  * initially after injury or
  * after surgical debridement
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information/ICF
  * Willingness and ability to participate in the clinical investigation according to the registry plan
  * Signed and dated EC/IRB approved written informed consent OR
  * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent

Exclusion Criteria:

* Any oblique defect that has less than 8cm expansion when adding the defect size of all four cortices
* Any not medically managed severe systemic disease
* Pregnancy
* Prisoners
* Participation in any other medical device or medicinal product registry within the previous 3 months that could influence the results of the present registry

Primary outcomes:
measure: Baseline characteristics
timeFrame: Pre-operative
measure: Bone defect details
timeFrame: Pre-operative and/or intraoperative
measure: Trauma assessment
timeFrame: Pre-operative and/or intraoperative
measure: evaluate the bone defect in the context of previous interventions
timeFrame: Intraoperative
measure: Surgical details & Intraoperative findings 1
timeFrame: Intraoperative
measure: Surgical details & Intraoperative findings 2
timeFrame: Intraoperative
measure: Functional Outcome
timeFrame: 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 12 months)
measure: Patient related outcome / Quality of life 1
timeFrame: Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
measure: Patient related outcome / Quality of life 2
timeFrame: Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
measure: Radiological Outcome
timeFrame: Screening / / Intraoperative / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedar Sinai
state: California
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Mayfield Heights
country: United States
facility: Cleveland Clinic
state: Ohio
city: Buenos Aires
country: Argentina
facility: Hospital Italiano Buenos Aires
city: Newcastle
country: Australia
facility: John Hunter Hospital
city: Rio De Janeiro
country: Brazil
facility: Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
city: Valdivia
country: Chile
facility: Hospital Base Valdivia
city: Bogotá
country: Colombia
facility: Hospital Universitario de la Samaritana
city: Medellín
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
city: Gießen
country: Germany
facility: Universitätsspital Gießen
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg (Unfallchirurgie)
city: Münster
country: Germany
facility: Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)
city: Patna
country: India
facility: Paras HMRI Hospital Patna
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital (Orthopaedics)
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht (Dept. of Surgery)
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich (Klinik für Traumatologie)
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)
Study officials:
affiliation: University Hospital Zurich Department of Trauma Surgery
name: Hans-Christoph Pape, MD
role: PRINCIPAL_INVESTIGATOR
References: