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

Overview

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.

Interventions

• Procedure Any treatment that is used for a defect of any long bone
  Any treatment that is used for a defect of any long bone. All treatments are based on individual clinician's judgement and the patient characteristics. The registry does not dictate any specific treatment.

Primary outcome measures

• Baseline characteristics [Time frame: Pre-operative]
• Bone defect details [Time frame: Pre-operative and/or intraoperative]
• Trauma assessment [Time frame: Pre-operative and/or intraoperative]
• evaluate the bone defect in the context of previous interventions [Time frame: Intraoperative]
• Surgical details & Intraoperative findings 1 [Time frame: Intraoperative]
• Surgical details & Intraoperative findings 2 [Time frame: Intraoperative]
• Functional Outcome [Time frame: 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 12 months)]
• Patient related outcome / Quality of life 1 [Time frame: Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)]
• Patient related outcome / Quality of life 2 [Time frame: Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)]
• Radiological Outcome [Time frame: Screening / / Intraoperative / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Germany · 5 centers

• University Hospital Frankfurt — Frankfurt
• Universitätsspital Gießen — Giessen
• Universitätsklinikum Heidelberg (Unfallchirurgie) — Heidelberg
• Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellu — Münster
• Krankenhaus Johanneum — Wildeshausen

United States · 2 centers

• Cedar Sinai — Los Angeles
• Sinai Hospital of Baltimore — Baltimore

Colombia · 2 centers

• Hospital Universitario de la Samaritana — Bogotá
• Hospital Pablo Tobon Uribe — Medellín

Netherlands · 2 centers

• Academisch Ziekenhuis Maastricht (Dept. of Surgery) — Maastricht
• Radboud University Medical Center — Nijmegen

Australia · 1 center

• John Hunter Hospital — Newcastle

Brazil · 1 center

• Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia — Rio de Janeiro

Chile · 1 center

• Hospital Base Valdivia — Valdivia

India · 1 center

• Paras HMRI Hospital Patna — Patna

South Africa · 1 center

• Tygerberg Hospital — Cape Town

South Korea · 1 center

• Kyungpook National University Hospital (Orthopaedics) — Daegu

Switzerland · 1 center

• Universitätsspital Zürich (Klinik für Traumatologie) — Zurich

Ukraine · 1 center

• Central Hospital of Border Guard Service of Ukraine — Kyiv

United Kingdom · 1 center

• Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery) — Leeds

Venezuela · 1 center

• Hospital Universitario de Caracas — Caracas

Identifiers

NCT: NCT04112992 · LoBoDe Registry

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗