Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04112992
Other study ID # LoBoDe Registry
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT04043286 - The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels N/A
Recruiting NCT03046147 - The Effect of Roux-en-Y Gastric Bypass on Bone Turnover N/A
Completed NCT01292395 - Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency N/A
Completed NCT00485953 - Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy Phase 4
Completed NCT00674453 - The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation Phase 2
Completed NCT00181584 - Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer Phase 2
Withdrawn NCT04380155 - Cycling Duration and Bone Markers in in Active Young Adults N/A
Active, not recruiting NCT04779216 - Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa Phase 3
Completed NCT05371418 - Comparative Clinical and Radiographical Evaluation of Treatment of Angular Bone Defect Related to Over Erupted Tooth Using GTR Followed by Orthodontic Intrusion Versus Orthodontic Intrusion Followed by GTR N/A
Not yet recruiting NCT04345250 - Bone Response to Exercise and Energy Restriction in Young Adults N/A
Active, not recruiting NCT05301400 - Marginal Bone Loss in Single Implant Restaurations With Different Methods N/A
Active, not recruiting NCT05405894 - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Recruiting NCT04983758 - 20-year Implant Survival in Periodontally Healthy and Compromised Patients
Recruiting NCT04713774 - Bone Density and Vascular Calcifications Evolution After Renal Transplant
Completed NCT04279392 - Healthy Body, Healthy Bones After Bariatric Surgery Trial Phase 1/Phase 2
Completed NCT04332679 - Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes N/A
Completed NCT05721014 - Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health N/A
Recruiting NCT04883502 - Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
Not yet recruiting NCT05066815 - Evaluation of Crestal Bone Loss Around Short Dental Implants As Affected By Two Suprastructure Materials N/A
Completed NCT03292146 - Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study Phase 3