MRI Evaluation of Graft Maturation Following ACL Reconstr... | NCT07046000

NCT07046000

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Label	Type	Description	Intervention Names
ACL Reconstruction with Allograft		Subjects who have undergone ACL reconstruction with allograft	Diagnostic Test: MRI

Name	Type	Description	Arm Group Labels	Other Names
MRI	Diagnostic Test	MRI to assess graft maturation	ACL Reconstruction with Allograft

Measure	Description	Time Frame
Graft Maturation via MRI	The signal to noise ratio will be calculated at the proximal, mid-substance, and distal positions of the graft	From 4.5 months post surgery until 12 months or graft maturation.

Eligibility Module

Eligibility Criteria

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.