Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-26
SponsorMarshall University

About this trial

The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients must be age 14-26 years old.

Skeletally mature patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft augmentation.

Patients must be a tanner stage of 5 and a posteroanterior left hand film x-ray will be obtained to confirm bone age and skeletal maturity

Patients with associated meniscal and chondral pathology (except patients falling into

Disqualifiers

An understanding of the purpose of the study and providing written informed consent.

Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction),

Patients who have undergone previous ACL reconstructive surgery.

Patients who are currently pregnant or nursing.

Trial population

patients 14-26 years old with ACL ruptures

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fertilized ACL

    Procedure/Surgery

    Fertilized ACL is an acl reconstruction with Bone marrow aspirate, demineralized bone matrix, and an internal brace.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Treatment1 intervention
Group B: Control0 interventions

Trial outcomes

Primary outcomes

1

Return to play

Patient will be monitored for return to play at their sport

Time frame
6 months after surgery until study conclusion
2

Biomechanics testing

Patient will undergo hop testing for limb symmetry

Time frame
4.5 months after surgery and 6 months after surgery

Secondary outcomes

1

MRI findings

At 6 months, all subjects will undergo magnetic resonance imaging (MRI) of the operative extremity to investigate bone healing between groups. Imaging for this time-point is paid for by the grant/sponsor; there is no cost to the subject, and it is NOT submitted to insurance.

Time frame
6 months after surgery

Other outcomes

1

Rerupture

Patients will be asked if they have a rerupture of their graft at 2 years after surgery

Time frame
2 years after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marshall University

Lead sponsor

Arthrex, Inc.

Collaborator