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Does Bone Grafting at the Time of Bone-Patellar Tendon-Bone ACL Reconstruction Reduce the Incidence of Post-operative Anterior Knee Pain: A Randomized Controlled Clinical Study

NCT04958733 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-05

No results posted yet for this study

Summary

It is estimated that 48 out of 10,000 people, in the United States, will tear their anterior cruciate ligament (ACL) annually and undergo ACL reconstruction (ACLR). Surgeons have several graft options, surgical techniques, and fixation methods to consider when planning how to reconstruct a patient's ACL. Graft options vary greatly and include allografts and autografts with good evidence that are good choices. Further, autografts include several different specific grafts including; bone-patellar tendon-bone (BPTB), hamstring tendons, and quadriceps tendon. There is no clear consensus on which graft type is superior, as each graft has associated positives and negatives.

Historically, autologous BPTB grafts have been the preferred choice of surgeons given its ability to restore rotational stability for the knee, the robust healing with direct bone-to-bone contact at both ends of the graft, and low failure rates. However, there are drawbacks to ACLR using a BPTB graft. Complications following BPTB graft harvesting include patella fractures, patellar tendon ruptures, increased risk of patellofemoral osteoarthritis, lack of terminal extension, and donor-site morbidity. The majority of these complications are associated with low-risk rates, except for donor-site morbidity which may be prevalent in 37-51% of BPTB graft patients. Donor-site pain can manifest as anterior knee, patellofemoral pain, loss of sensory input, or discomfort with kneeling and can negatively influence subjective as well as objective measures of knee function.

Filling bony defects with bone graft is a procedure that is commonly conducted within orthopedics. However, its use in treating the bony defects caused during BPTB graft harvesting is less common as patella and tibial harvest sites are routinely left unfilled. Significant methodological differences in treatment interventions for the patella harvest site, the tibial harvest site, or both and conflicting results have made it difficult to determine if these treatments have clinical utility. To the best of the investigators' knowledge, there has been no investigation looking at the incidence of donor site morbidity treated with autologous bone grafting of the harvest sites. Therefore, the purpose of this study is to determine if filling the harvest site defect is associated with a lower rate of donor site morbidity and better patient reported functional outcomes compared to patients whose harvest site remains unfilled.

The purpose of this study is to compare the rate of donor site morbidity between patients who have their harvest sites bone grafted with autologous bone (BG) and those whose harvest sites remain unfilled (nBG).

Conditions

  • ACL Injury

Interventions

PROCEDURE

Autologous bone grafting

Autologous bone grafting is the excess bone obtained from graft preparation and the coring reamer

PROCEDURE

Absence of autologous bone grafting

Donor sites will be left unfilled

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2023-06-30
Completion
2024-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04958733 on ClinicalTrials.gov