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

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04112992
• Other study ID #: LoBoDe Registry
• Status: Not yet recruiting
• Start date: April 30, 2024
• Est. completion date: March 30, 2029

Study information

• Verified date: March 2024
• Source: AO Innovation Translation Center
• Contact: Alix Frischknecht
• Phone: +41 79 606 41 48
• Email: alix.frischknecht[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 30, 2029
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Loss
• Limb Fracture

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt
Germany	Universitätsklinikum Heidelberg (Unfallchirurgie)	Heidelberg
Germany	Universitätsklinikum Münster (Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie)	Münster
Korea, Republic of	Kyungpook National University Hospital (Orthopaedics)	Daegu
Netherlands	Academisch Ziekenhuis Maastricht (Dept. of Surgery)	Maastricht
Switzerland	Universitätsspital Zürich (Klinik für Traumatologie)	Zürich
United Kingdom	Leeds General Infirmary University Hospital (Trauma & Orthopaedic Surgery)	Leeds
United States	Ascension St. John Medical Center (Orthopaedics)	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
AO Innovation Translation Center

Countries where clinical trial is conducted

United States,  Germany,  Korea, Republic of,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline characteristics	Demographics, medical history, comorbidity	Pre-operative
Primary	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
Primary	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
Primary	evaluate the bone defect in the context of previous interventions	Number of previous interventions: <2, <4, >4	Intraoperative
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)