Tibial Delayed Healing Pivotal Clinical Trial

Inclusion criteria

• ✓. Has tibial delayed healing. A subject will be considered to have delayed healing when he/she is at least six months from the date of the most recent surgical intervention and has shown no signs of radiographic healing for at least three months. (Radiographic signs of healing for this study are defined as either the progressive disappearance of fracture lines or the development of cortical continuity \[bridging bone\] at the site.)
• ✓. Has delayed healing of the tibia that requires treatment with rigid internal fixation and bone grafting. (Stable rigid internal fixation hardware may already be in place prior to treatment. If required, the fixation hardware may be removed and replaced along with the placement of the bone graft.)
• ✓. Has adequate soft tissue coverage at the delayed healing site. All prior soft tissue coverage procedures (e.g., skin grafts or flaps) should be sufficiently healed for placement of a bone graft prior to enrollment in the study.
• ✓. Has a sufficient amount of iliac crest autograft available for a bone grafting procedure.
• ✓. After walking 5 or 6 steps, has intensity of pain/discomfort at the injury site equal to or greater than 4 (as reported on the preoperative Delayed Healing Site Pain Questionnaire form; 0 being no pain and 10 being pain as bad as it could be).
• ✓. Is at least 21 years of age and skeletally mature at the time of surgery.
• ✓. If a female of child-bearing potential, patient is not pregnant or nursing and agrees not to become pregnant for one year following surgery in the study.
• ✓. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

Exclusion criteria