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

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: Not yet recruiting
• Conditions: Bone Loss; Limb Fracture
• Intervention / Treatment: Procedure: Any treatment that is used for a defect of any long bone

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: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Alix Frischknecht; Phone Number: +41 79 606 41 48; Email: alix.frischknecht@aofoundation.org
• Study Contact Backup: Name: Joelle Kägi; Email: joelle.kaegi@aofoundation.org

Study Locations

• Germany
  • Frankfurt, Germany
    • University Hospital Frankfurt
    • Contact: Ingo Marzi, MD; Email: marzi@trauma.uni-frankfurt.de
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg (Unfallchirurgie)
    • Contact: Gerhard Schidmaier, MD; Phone Number: +49 1622 999 553; Email: gerhard.schmidmaier@med.uni-heidelberg.de
  • Münster, Germany
    • Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)
    • Contact: Steffen Rosslenbroich, MD; Email: Steffen.Rosslenbroich@ukmuenster.de
• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital (Orthopaedics)
    • Contact: Chang-Wug Oh, MD; Email: cwoh@knu.ac.kr
• Netherlands
  • Maastricht, Netherlands
    • Academisch Ziekenhuis Maastricht (Dept. of Surgery)
    • Contact: Martijn Poeze, MD; Phone Number: +31433871956; Email: m.poeze@mumc.nl
• Switzerland
  • Zürich, Switzerland
    • Universitätsspital Zürich (Klinik für Traumatologie)
    • Contact: Hans-Christoph Pape, MD; Phone Number: + 41 (0)44 255 27 55; Email: Hans-Christoph.Pape@usz.ch
• United Kingdom
  • Leeds, United Kingdom
    • Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)
    • Contact: Peter Giannoudis, MD; Email: peter.giannoudis@nhs.net
• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Ascension St. John Medical Center (Orthopaedics)
      • Contact: Brent Norris, MD; Email: brent.norris@otsok.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 injuryFace worst injuryChest worst injuryAbdomen worst injuryExtremity (including pelvis) worst injuryExternal worst injury; Gustilo & Anderson classification for open fracturesType IType IIType IIIAType IIIBType IIIC; Tscherne classification for closed fracture and soft-tissue injuriesGrade 0Grade 1Grade 2Grade 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 stageStaged (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; OthersSurgical 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 graftingAutograftsAllograft(s)Other syntheticsIf applicable - time to harvest graft (in minutes); Graft enhancement yes / noDemineralized bone matrix (DBM)Bone morphogenetic protein (BMP)Stem cellsPlatelet rich plasma (PRP)Other; Soft-tissue / vascular / microsurgical procedure yes / noSkin graftLocal flapFree flap; Additional treatmentSystemic antibiotic treatment yes / noLocal antibiotic treatment yes / noPost-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)

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Hans-Christoph Pape, MD, University Hospital Zurich Department of Trauma Surgery

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: long bone defect
• Other Study ID 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