An International, Multicenter, Prospective Registry on Post-traumatic Long Bones Defects

NCT04112992 | Recruiting

• 1 other identifier: LoBoDe Registry
• Study Type: observational
• Target: 600
• Locations: 14 countries
• Sites: 21

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.

Conditions

Limb Fracture; Bone Loss

Keywords

long bone defect

Outcome Measures

Primary Outcomes (10)

• Baseline characteristics

  Demographics, medical history, comorbidity

  Pre-operative

• Bone defect details

  * Affected bone * Localization: Proximal 1/3rd, middle 3rd, distal 1/3rd(for any bone) * Size (categorization according Karger classification; definition: a bone defect should be at least 2 cm (Karger Type II)) Type II: 2-5 cm Type III: 5-10 cm Type IV: \> 10 cm

  Pre-operative and/or intraoperative

• Trauma assessment

  * Injury Severity Score (ISS): Grading for each item (points): No injury (0), Minor (1), Moderate (4), Serious (9), Severe (16), Critical (25), Unsurvivable (75) * Assessment: * Head and neck worst injury * Face worst injury * Chest worst injury * Abdomen worst injury * Extremity (including pelvis) worst injury * External worst injury * Gustilo \& Anderson classification for open fractures * Type I * Type II * Type IIIA * Type IIIB * Type IIIC * Tscherne classification for closed fracture and soft-tissue injuries * Grade 0 * Grade 1 * Grade 2 * Grade 3

  Pre-operative and/or intraoperative

• evaluate the bone defect in the context of previous interventions

  Number of previous interventions: \<2, \<4, \>4

  Intraoperative

• Surgical details & Intraoperative findings 1

  * Procedure type: * One stage * Staged (e.g. Masquelet technique / distraction osteogenesis / bone transport) * Ilizarov * Bone quality (good, fair, poor) by surgeon's discretion * Soft tissue and vascularity (good, fair, poor) by surgeon's discretion * Contamination (yes/no) Specification: * Metal from a bullet * Metal from a pole * Other Metal * Wood * Soil * Others * Surgical time (min) * Stabilization technique: Internal device (extra- or intramedullary) / External device (For both, drop down menu will be used)

  Intraoperative

• Surgical details & Intraoperative findings 2

  * Bone grafting * Autografts * Allograft(s) * Other synthetics * If applicable - time to harvest graft (in minutes) * Graft enhancement yes / no * Demineralized bone matrix (DBM) * Bone morphogenetic protein (BMP) * Stem cells * Platelet rich plasma (PRP) * Other * Soft-tissue / vascular / microsurgical procedure yes / no * Skin graft * Local flap * Free flap * Additional treatment * Systemic antibiotic treatment yes / no * Local antibiotic treatment yes / no * Post-operative use of a negative pressure dressings (NPWT) or vacuum-assisted closure (VAC) system yes / no

  Intraoperative

• Functional Outcome

  \- Assessment of limb function and loss of length * Definition: anatomic shortening of the limb in comparison to the contralateral side * Assessment in cm * Any orthotic used to equalize leg length

  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

  Patient-Reported Outcomes Measurement Information System (PROMIS) * Physical function: This item measures self-reported capability rather than actual performance. It includes the functioning of lower extremities (walking or mobility) as well as instrumental activities of daily living, such as running errands. We will use the short form 10b. * Physical function, upper extremity: This item measures activities that require use of the upper extremity including shoulder, arm, and hand activities. Examples include writing, using buttons, or opening containers. We will use the short form 7. * Pain Interference: This item assesses self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. We will use the short form 8a. Short forms will be used in all sites possible (i.e. where the translation is available).

  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

  EQ-5D-3L assessment (Five items, 3-point categorical scale) The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. o The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

  Screening / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)

• Radiological Outcome

  Pre-operative/intraoperative * Deformity parameters (if applicable) * Nonunion classification: Hypertrophic, Oligotrophic, Atrophic Follow-up visits * Bone healing (based on the treating physician's judgement): Not healed / Partially healed / Mostly healed / Healed * Evaluation of the expansion of the bone defect: bone defect size * Time to healing: Date when full healing is achieved (to be calculated days from index surgery)

  Screening / / Intraoperative / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months)

Interventions

Any treatment that is used for a defect of any long bone PROCEDURE

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.

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 with a traumatic bone defect in any long bone

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (21)

Cedar Sinai

Los Angeles, California, 90048, United States

RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

John Hunter Hospital

Newcastle, 2310, Australia

RECRUITING

Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia

Rio de Janeiro, 22430-160, Brazil

RECRUITING

Hospital Base Valdivia

Valdivia, 5090146, Chile

RECRUITING

Hospital Universitario de la Samaritana

Bogotá, 110411, Colombia

SUSPENDED

Hospital Pablo Tobon Uribe

Medellín, Colombia

RECRUITING

University Hospital Frankfurt

Frankfurt, Germany

RECRUITING

Universitätsspital Gießen

Giessen, 35385, Germany

RECRUITING

Universitätsklinikum Heidelberg (Unfallchirurgie)

Heidelberg, Germany

TERMINATED

Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)

Münster, Germany

RECRUITING

Krankenhaus Johanneum

Wildeshausen, 27793, Germany

NOT YET RECRUITING

Paras HMRI Hospital Patna

Patna, 800014, India

RECRUITING

Academisch Ziekenhuis Maastricht (Dept. of Surgery)

Maastricht, Netherlands

RECRUITING

Radboud University Medical Center

Nijmegen, 6525, Netherlands

RECRUITING

Tygerberg Hospital

Cape Town, 7505, South Africa

NOT YET RECRUITING

Kyungpook National University Hospital (Orthopaedics)

Daegu, South Korea

RECRUITING

Universitätsspital Zürich (Klinik für Traumatologie)

Zurich, Switzerland

RECRUITING

Central Hospital of Border Guard Service of Ukraine

Kyiv, Ukraine

NOT YET RECRUITING

Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)

Leeds, United Kingdom

NOT YET RECRUITING

Hospital Universitario de Caracas

Caracas, Venezuela

NOT YET RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hans-Christoph Pape, MD

  University Hospital Zurich Department of Trauma Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Minoia

CONTACT

+41 79 612 09 67; marco.minoia@aofoundation.org

Joelle Kägi

CONTACT

+41 79 549 32 83; joelle.kaegi@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: July 3, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

UA (1); VE (1); US (2); GB (1); CL (1); KR (1); ZA (1); AU (1); BR (1); DE (5); IN (1); NL (2); CO (2); CH (1)