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

August 28, 2025 updated by: AO Innovation Translation Center

An International, Multicenter, Prospective Registry to Investigate Treatment Options and Their Outcomes on Post-traumatic Long Bones Defects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
  • Brazil
      • Rio de Janeiro, Brazil, 22430-160
        • Recruiting
        • Hospital Municipal Miguel Couto Serviço de Ortopedia e Traumatologia
        • Contact:
  • Chile
  • Colombia
      • Bogotá, Colombia, 110411
        • Suspended
        • Hospital Universitario de la Samaritana
      • Medellín, Colombia
        • Recruiting
        • Hospital Pablo Tobon Uribe
        • Contact:
  • Germany
      • Frankfurt, Germany
      • Giessen, Germany, 35385
      • Heidelberg, Germany
        • Terminated
        • Universitätsklinikum Heidelberg (Unfallchirurgie)
      • Münster, Germany
        • Recruiting
        • Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)
        • Contact:
      • Wildeshausen, Germany, 27793
  • India
      • Patna, India, 800014
        • Recruiting
        • Paras HMRI Hospital Patna
        • Contact:
  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • Academisch Ziekenhuis Maastricht (Dept. of Surgery)
        • Contact:
      • Nijmegen, Netherlands, 6525
  • South Africa
      • Cape Town, South Africa, 7505
  • South Korea
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Hospital (Orthopaedics)
        • Contact:
  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • Universitätsspital Zürich (Klinik für Traumatologie)
        • Contact:
  • Ukraine
      • Kyiv, Ukraine
        • Not yet recruiting
        • Central Hospital of Border Guard Service of Ukraine
        • Contact:
        • Principal Investigator:
          • Dmytro Smolianets
  • United Kingdom
      • Leeds, United Kingdom
        • Not yet recruiting
        • Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)
        • Contact:
  • United States
    • California
      • Los Angeles, California, United States, 90048
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Contact:
          • Janet Conway
  • Venezuela
      • Caracas, Venezuela
        • Not yet recruiting
        • Hospital Universitario de Caracas
        • Contact:
        • Principal Investigator:
          • Manuel Malaret
        • Sub-Investigator:
          • Igor Escalante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a traumatic bone defect in any long bone

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline characteristics
Time Frame: Pre-operative
Demographics, medical history, comorbidity
Pre-operative
Bone defect details
Time Frame: Pre-operative and/or intraoperative
  • 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
Time Frame: Pre-operative and/or intraoperative
  • 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
Time Frame: Intraoperative
Number of previous interventions: <2, <4, >4
Intraoperative
Surgical details & Intraoperative findings 1
Time Frame: Intraoperative

  • 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
Time Frame: Intraoperative

  • 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
Time Frame: 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 12 months)

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

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

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AO Innovation Translation Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hans-Christoph Pape, MD, University Hospital Zurich Department of Trauma Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LoBoDe Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Loss

Clinical Trials on Any treatment that is used for a defect of any long bone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings