MRI Evaluation of Graft Maturation Following ACL Reconstruction

Magnetic Resonance Imaging (MRI) Evaluation of Graft Maturation Following Anterior Cruciate Ligament (ACL) Reconstruction With a Connective Tissue Allograft

Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.

Inclusion Criteria:

• ACL tear and reconstruction; no other knee ligaments needing reconstruction
• Primary (first-time) ACL tear in the affected knee
• ACL injury occurred less than 12 months before ACL reconstruction
• Have no contraindications or allergies to the treatment administered
• Have current imaging studies (plain radiographs and MRI exams within the past 12 months) of the knee to rule out other etiologic diagnoses
• Patient underwent ACL reconstruction with a Bone-Patellar Tendon-Bone (BTB) graft harvested from the same knee (ipsilateral autograft) with the Active Matrix tissue
• Able and willing to comply with the post-operative study follow-up schedule

Exclusion Criteria:

• Prior surgery on the index knee within 12 months of enrollment
• Steroid injection into the index knee within 6 weeks of enrollment
• Chronic ACL tear whereas the injury occurred more than 12 months ago
• Multiligamentous injuries whereas any ligament (MCL, PCL, or PLC) in addition to the ACL needs to be reconstructed
• Patient underwent ACL reconstruction with a hamstring tendon, Achilles tendon or quadriceps tendon graft (any graft other than a patellar tendon BTB)
• Contraindication to MRI (eg, implanted devices incompatible with MRI).
• Chrondral lesion of the knee that requires treatment during ACL reconstruction surgery
• History of advanced osteoarthritis of the knee or patella-femoral joint; KL grade III or higher
• History of malignant tumor and osseous metastatic disease,
• History of chronic pain disorders (i.e., fibromyalgia),
• Current substance abuse (drug or alcohol), by the investigator's judgment,
• Females who are pregnant, nursing or breastfeeding, or who intend to become pregnant during participation in the study.
• Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,
• Currently involved in any injury litigation or workers compensation claims,
• Has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.