Recruiting

Observational Study

Sponsor:

AO Innovation Translation Center

Code:

NCT04112992

Conditions

Limb Fracture

Bone Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT04112992

Start date

Jul 3, 2024

Status verified date

Aug, 2025

Completion date

Mar 30, 2029

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Baseline characteristics [ Time Frame: Pre-operative ]
  • Bone defect details [ Time Frame: Pre-operative and/or intraoperative ]
  • Trauma assessment [ Time Frame: Pre-operative and/or intraoperative ]
  • evaluate the bone defect in the context of previous interventions [ Time Frame: Intraoperative ]
  • Surgical details & Intraoperative findings 1 [ Time Frame: Intraoperative ]
  • Surgical details & Intraoperative findings 2 [ Time Frame: Intraoperative ]
  • Functional Outcome [ Time Frame: 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 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) ]
  • Radiological Outcome [ Time Frame: Screening / / Intraoperative / 6 months follow-up / 12 months follow-up and/or 6 months after bone union (max 18 months) ]

Central Contacts and Locations

Central contacts

Marco Minoia

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

Joelle Kägi

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

Locations

Cedar Sinai

Recruiting

Los Angeles, California, United States, 90048

Contacts

Geoffrey Marecek, MD

Geoffrey.Marecek@cshs.org

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

More Information

Sponsor

AO Innovation Translation Center

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Keywords

  • long bone defect

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AO Innovation Translation Center on 2025-08-29.