Recruiting

Bone Grafting

Sponsor:

Hartford Hospital

Code:

NCT04958733

Conditions

ACL Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Autologous bone grafting

Absence of autologous bone grafting

Study Details

Brief 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

Study ID

NCT04958733

Start date

Sep 3, 2021

Status verified date

Aug, 2022

Completion date

Jun, 2024

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and females
  • 18 years of age and older, with no upper age limit
  • A candidate for primary autologous BPTB ACLR
  • Willing to participate in the study

Exclusion Criteria:

  • Concomitant ligamentous or chondral injury
  • Prior surgery on the index knee
  • Prior history of anterior knee pain or patellofemoral joint pain on the index knee
  • Outerbridge classification > 2 assessed during arthroscopy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Autologous Bone Grafting

Excess bone obtained from graft preparation and the coring reamer will be used to fill the patellar and tibial donor sites.

placebo comparator: Control

The control group will have their patellar and tibial defects remain unfilled.

Interventions

Autologous bone grafting

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

Absence of autologous bone grafting

Donor sites will be left unfilled

Primary outcome measure

  • Visual Analog Scale [ Time Frame: pre-op ]
  • Visual Analog Scale [ Time Frame: post-op month 6 ]
  • Visual Analog Scale [ Time Frame: post-op month 12 ]
  • Visual Analog Scale [ Time Frame: post-op month 24 ]
  • Direct Palpation of Harvest Site [ Time Frame: pre-op ]
  • Direct Palpation of Harvest Site [ Time Frame: post-op month 6 ]
  • Direct Palpation of Harvest Site [ Time Frame: post-op month 12 ]
  • Direct Palpation of Harvest Site [ Time Frame: post-op month 24 ]
  • Pain with Kneeling [ Time Frame: pre-op ]
  • Pain with Kneeling [ Time Frame: post-op month 6 ]
  • Pain with Kneeling [ Time Frame: post-op month 12 ]
  • Pain with Kneeling [ Time Frame: post-op month 24 ]

Central Contacts and Locations

Central contacts

Locations

Bone and Joint Institute at Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Orthopedic Associates of Hartford

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Principal Investigator:

Clifford Rios, MD

PRISM Sports Medicine

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Principal Investigator:

Carl Nissen, MD

More Information

Sponsor

Hartford Hospital

Last update posted

Aug 5, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2022-08-05.