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Not yet recruiting NCT07310082

Allograft vs. Autograft Nonunion

No phase Interventional Nonunion Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autograft, Allograft.
Who it may be relevant to
Registry conditions: Nonunion Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Allograft vs. Autograft to Improve Timely Return to Duty Following Nonunion

Overview

The purpose of this research study is to find out if patients treated for nonunion fracture with autograft or allograft return to activity faster.

Detailed description

The goal of this multi-center prospective randomized controlled trial is to compare short and long-term outcomes of adult patients with long-bone nonunion treated with autograft versus allograft. The main question it aims to answer is: will patients who receive an allograft return to work faster than patients who receive an autograft to treat nonunion fracture.

Participants will be randomized to one of two treatment groups and will complete follow-up surveys during their recovery.

Interventions

  • Procedure Autograft
    Surgeons will decide on the location and method of donor site based on the clinical situation. Most commonly, bone graft will be harvested from the anterior or posterior iliac crest or utilizing the Reamer Irrigator Aspirator in an appropriate long bone. Surgeons may choose to harvest autograft from proximal tibia or distal femur. Donor site location is at the discretion of treating surgeon for patients who randomize to autograft. This treatment arm will not include local autograft only. For lar
  • Procedure Allograft
    Allograft bone will consist of cancellous or corticocancellous sterile packaged human cadaveric bone. No bone morphogenetic protein, bone marrow aspirate, or other biologic augment will be added. Demineralized bone matrix may be added at the surgeon's discretion. This allograft will be applied to the nonunion site using the surgeon's typical technique. Internal fixation, revision of fixation, and/or augmentation of fixation will be performed at the discretion of the surgeon.

Primary outcome measures

  • Metabolic Equivalent for Tasks Score [Time frame: Week 6]
  • Metabolic Equivalent for Tasks Score [Time frame: Month 3]
  • Metabolic Equivalent for Tasks Score [Time frame: Month 6]
  • Metabolic Equivalent for Tasks Score [Time frame: Month 12]
  • Average Time to Return to Work/Duty [Time frame: Week 6]
  • Average Time to Return to Work/Duty [Time frame: Month 3]
  • Average Time to Return to Work/Duty [Time frame: Month 6]
  • Average Time to Return to Work/Duty [Time frame: Month 12]
  • Number of Participants Returned to Work [Time frame: Week 6]
  • Number of Participants Returned to Work [Time frame: Month 3]
Secondary outcome measures (12)
  • Percentage of Union [Time frame: Week 6, Month 3, Month 6, Month 12]
  • Time to Union [Time frame: Week 6, Month 3, Month 6, Month 12]
  • Radiographic Union Scale in Tibial fractures (RUST) score [Time frame: Month 12]
  • Number of Participants who Return to the Operating Room [Time frame: Week 6, Month 3, Month 6, Month 12]
  • PROMIS-29 Subscale - Physical Function [Time frame: Week 6, Month 3, Month 6, Month 12]
  • PROMIS-29 Subscale - Anxiety [Time frame: Week 6, Month 3, Month 6, Month 12]
  • PROMIS-29 Subscale - Depression [Time frame: Week 6, Month 3, Month 6, Month 12]
  • PROMIS-29 Subscale - Fatigue [Time frame: Week 6, Month 3, Month 6, Month 12]
  • PROMIS-29 Subscale - Sleep Disturbance [Time frame: Week 6, Month 3, Month 6, Month 12]
  • PROMIS-29 Subscale - Pain Interference [Time frame: Week 6, Month 3, Month 6, Month 12]
  • PROMIS-29 Subscale - Ability to Participate in Social Roles and Activities [Time frame: Week 6, Month 3, Month 6, Month 12]
  • Number of Resource Utilizations [Time frame: Week 6, Month 3, Month 6, Month 12]

Eligibility criteria

Inclusion criteria

  • Patients 18 years or older
  • Long bone (tibia, femur, and humerus) nonunion appropriate for either study treatment: to be treated with bone graft harvested from a remote site or using reamer harvester (RIA)
  • Nonunion surgery to be performed at least five months after initial fracture fixation
  • Prior operative fixation of fracture
  • Radiographic apparent bone gap (RABG) of >5cm

Exclusion criteria

  • Patient that speaks neither English nor Spanish
  • Patients whose treatment plan includes local autograft only (available callus from the nonunion site or no planned bone graft)
  • Known active infection (defined as any clinical signs or symptoms of active infection, such as fevers, wound redness, warmth, swelling, induration or drainage, and abnormal while blood cell count, erythrocyte sedimentation rate, or C-reactive protein) being treated with antibiotics
  • Body mass index greater than 50
  • Patients unlikely to follow-up due to homelessness, or planning follow-up at another institution
  • Prisoner

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Atrium Health Carolinas Medical Center — Charlotte

Identifiers

NCT: NCT07310082 · IRB00140521 · HT9425-25-1-0424

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗