Carbon Fiber Implants

NCT03382041 | Terminated Results DMC FDA Device

• 1 other identifier: F160824002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will compare intramedullary nailing of open and closed tibia shaft fractures with carbon fiber implant versus titanium implant in a Level I trauma setting.

Conditions

Tibial Shaft Fractures

Outcome Measures

Primary Outcomes (2)

• The Number of Participants Identified With Fracture Healing

  Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.

  From baseline through 6 weeks.

• The Number of Participants Identified With Fracture Healing

  Will assess radiographically the fracture healing for patients treated with Carbon Fiber and Titanium Implants.

  From baseline through 3 months.

Secondary Outcomes (20)

• Short Musculoskeletal Function Assessment Questionnaire (SMFA).

  6 months

• Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.

  6 months

• Short Musculoskeletal Function Assessment Questionnaire (SMFA).

  12 months.

• Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.

  12 months.

• Short Musculoskeletal Function Assessment Questionnaire (SMFA) Score.

  18 months.

Study Arms (2)

Carbon Fiber Implant

EXPERIMENTAL

There is an alternative to the standard treatment, which is carbon fiber implants (tibial nails), especially in the prophylactic reinforcement of bones susceptible to pathological fractures following metastatic tumors. The new carbon fiber has also been used in the treatment of tibial non-union (non- healing bone); which has shown satisfactory outcomes.

Device: Carbon Fiber Implant

Titanium Implant

ACTIVE COMPARATOR

The standard of practice in the treatment of fractures of the tibial shaft and other long bones has been the intramedullary nailing using titanium or stainless steel implants.

Device: Titanium Implant

Interventions

Carbon Fiber Implant DEVICE

A cannulated rod, made of long carbon fiber reinforced polymer, with interlocking holes at its proximal and distal ends. The Nail provides for a slight bend. A Tantalum radiopaque marker along the Nail longitudinal axis provides for its visualization under fluoroscopy. The Nail proximal end is marked by a tantalum marker.

Carbon Fiber Implant

Titanium Implant DEVICE

An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body

Titanium Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Skeletal maturity (patients included will be 18 - 64 years, i.e. whose epiphyseal/growth plates are closed) ii. Arbeitsgemeinschaft ur Osteosynthesefragen/Orthpaedica Trauma Association (AO/OTA) Fracture class 42; open and closed tibia shaft fracture (Gustilo-Anderson Types I II, and III; Tscherne closed types 0, I, 2 and 3), Tscherne open types I and II.
• vi. Patient's informed consent or that of a legally acceptable representative

You may not qualify if:

• i. Subjects currently enrolled in one or more clinical studies ii. Skeletal immaturity (i.e. 17 years and younger) iii. Fractures planned for non-operative management iv. Complex intra-articular involvement of tibia plateau or distal tibia v. Pathologic fractures (fractures secondary to disease) vi. Concomitant ipsilateral tibia shaft fractures with complex pilon and/or plateau fractures requiring fixation vii. Patients already treated or in re-treatment viii. Tibia already infected as diagnosed by the attending physician ix. Patients likely to be lost before completing adequate follow-up, such as prisoners or planned out-of-state (and other likely problems in the investigator's judgment, with maintaining follow-up visit schedule) x. Patient is intellectually challenged or has a severe psychiatric condition xi. Patient is incompetent in the English Language xii. Patient is non-ambulatory before injury or as a consequence of polytrauma xiii. Inability to obtain patient's informed consent and/or that of a legally acceptable representative

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• CarboFix Orthopedics: collaborator

Study Sites (1)

The University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233, United States

Location

Results Point of Contact

• Title: Dr. Clay Spitler
• Organization: The University of Alabama at Birmingham (UAB)

caspitler@uabmc.edu

205-934-6413

Study Officials

• Clay A Spitler, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: The investigators will compare intramedullary nailing( placing a rod in the tibia) of open and closed tibia shaft fractures with carbon fiber implant (tibial nail) versus titanium implant (tibial nail) in a Level I trauma setting.

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: December 22, 2017
• Study Start: May 23, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2021
• Last Updated: July 25, 2023
• Results First Posted: March 2, 2022

Record last verified: 2023-07

Locations

US (1)