Health TrialsbyHealthPanel

Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction

ConditionsBone Graft; ComplicationsACL Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Arizona

About this trial

All patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. Patients will not be advised which group they belong to until after the completion of the study. One group will be treated with autologous bone graft for bone patellar-tendon bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR), and the other group will be treated with commercially available DBM (Demineralized bone matrix) putty. Patients will be enrolled from Banner University. Before and after surgery, patient reported outcomes including visual analog pain scale (VAS), Tegner-Lysholm and Cincinnati ACL Test. The principal investigator will evaluate the patients on subjective criteria such as pain and objective criteria including range of motion, arthritic changes seen on radiographs, infection, and ability to kneel.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-40 years old,

male/female/gender neutral,

all races not including vulnerable/special consideration populations,

candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft,

Disqualifiers

< 18, >41 years of age,

prior bone patellar bone anterior cruciate ligament reconstruction,

non-compliance post-operatively,

nicotine dependence.

Trial design

Design model

Parallel

Treatments tested in this trial

  • autologous bone grafts

    Procedure/Surgery

    group will be treated with autologous bone graft for BTB ACLR

  • Demineralized bone matrix (DBM)

    Other intervention

    Demineralized bone matrix (DBM) is a biologic allograft product derived from bone tissue that has undergone a process of demineralization to remove inorganic mineral components while retaining the organic matrix, including proteins and growth factors.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: autologous bone graftExperimental treatment 1 intervention
Group B: Demineralized bone matrix (DBM) puttyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

change in surgical time

Time frame
Duration of Procedure
2

Change in number of complications from the coring reamer intra-operatively

Time frame
Duration of Procedure
3

Change in number of complications associated with displacement of the bone graft

Time frame
1 year post procedure
4

Change in outcomes by immediately filling the patellar void following BTB graft harvest

Change in outcomes by immediately filling the patellar void following BTB graft harvest, as assessed by the Tegner-Lysholm Knee Scoring Scale

Time frame
1 year post procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

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

University of Arizona

Lead sponsor

Source ClinicalTrials.gov
Apply now