Allograft vs. Autograft Nonunion

NCT07310082 | Not Yet Recruiting

• 2 other identifiers: IRB00140521HT9425-25-1-0424
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nonunion Fracture

Keywords

Allograft; Autograft; Nonunion

Outcome Measures

Primary Outcomes (12)

• Metabolic Equivalent for Tasks Score

  Time to return to work/duty will be measured using the the International Physical Activity Questionnaire (IPAQ).The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient.

  Week 6

• Metabolic Equivalent for Tasks Score

  Time to return to work/duty will be measured using the the International Physical Activity Questionnaire (IPAQ).The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient.

  Month 3

• Metabolic Equivalent for Tasks Score

  Time to return to work/duty will be measured using the the International Physical Activity Questionnaire (IPAQ).The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient.

  Month 6

• Metabolic Equivalent for Tasks Score

  Time to return to work/duty will be measured using the the International Physical Activity Questionnaire (IPAQ).The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient.

  Month 12

• Average Time to Return to Work/Duty

  Average number of days it takes for participants to return to work/duty

  Week 6

• Average Time to Return to Work/Duty

  Average number of days it takes for participants to return to work/duty

  Month 3

• Average Time to Return to Work/Duty

  Average number of days it takes for participants to return to work/duty

  Month 6

• Average Time to Return to Work/Duty

  Average number of days it takes for participants to return to work/duty

  Month 12

• Number of Participants Returned to Work

  Determined by asking whether subjects have returned to work

  Week 6

• Number of Participants Returned to Work

  Determined by asking whether subjects have returned to work

  Month 3

• Number of Participants Returned to Work

  Determined by asking whether subjects have returned to work

  Month 6

• Number of Participants Returned to Work

  Determined by asking whether subjects have returned to work

  Month 12

Secondary Outcomes (16)

• Percentage of Union

  Week 6, Month 3, Month 6, Month 12

• Time to Union

  Week 6, Month 3, Month 6, Month 12

• Radiographic Union Scale in Tibial fractures (RUST) score

  Month 12

• Number of Participants who Return to the Operating Room

  Week 6, Month 3, Month 6, Month 12

• PROMIS-29 Subscale - Physical Function

  Week 6, Month 3, Month 6, Month 12

Study Arms (2)

Autograft

ACTIVE COMPARATOR

Patients randomized to autograft

Procedure: Autograft

Allograft

ACTIVE COMPARATOR

Patients randomized to allograft.

Procedure: Allograft

Interventions

Autograft PROCEDURE

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 large bone defects requiring expansion of autograft with allograft, this will be allowed and recorded. We will use intent-to-treat for statistical analysis of those with allograft expansion of autograft. This autograft 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.

Autograft

Allograft PROCEDURE

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.

Allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Fractures, Ununited

Interventions

Transplantation, Autologous; Transplantation, Homologous

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Joseph R Hsu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Churchill

CONTACT

704-355-6947; Christine.Churchill@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)