Clinical trial NCT04958733: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ACL Injury
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: pre-op
measure: Visual Analog Scale
timeFrame: post-op month 6
measure: Visual Analog Scale
timeFrame: post-op month 12
measure: Visual Analog Scale
timeFrame: post-op month 24
measure: Direct Palpation of Harvest Site
timeFrame: pre-op
measure: Direct Palpation of Harvest Site
timeFrame: post-op month 6
measure: Direct Palpation of Harvest Site
timeFrame: post-op month 12
measure: Direct Palpation of Harvest Site
timeFrame: post-op month 24
measure: Pain with Kneeling
timeFrame: pre-op
measure: Pain with Kneeling
timeFrame: post-op month 6
measure: Pain with Kneeling
timeFrame: post-op month 12
measure: Pain with Kneeling
timeFrame: post-op month 24
Secondary outcomes:
measure: PROMIS-10
timeFrame: pre-op
measure: PROMIS-10
timeFrame: post-op month 6
measure: PROMIS-10
timeFrame: post-op month 12
measure: PROMIS-10
timeFrame: post-op month 24
measure: International Knee Documentation Committee (IKDC) Subjective form
timeFrame: pre-op
measure: International Knee Documentation Committee (IKDC) Subjective form
timeFrame: post-op month 6
measure: International Knee Documentation Committee (IKDC) Subjective form
timeFrame: post-op month 12
measure: International Knee Documentation Committee (IKDC) Subjective form
timeFrame: post-op 24
measure: Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF)
timeFrame: pre-op
measure: Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF)
timeFrame: post-op month 6
measure: Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF)
timeFrame: post-op month 12
measure: Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF)
timeFrame: post-op month 24
measure: Marx Activity Scale
timeFrame: pre-op
measure: Marx Activity Scale
timeFrame: post-op month 6
measure: Marx Activity Scale
timeFrame: post-op month 12
measure: Marx Activity Scale
timeFrame: post-op month 24
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Bone and Joint Institute at Hartford Hospital
state: Connecticut
city: Hartford
country: United States
facility: Orthopedic Associates of Hartford
state: Connecticut
city: Hartford
country: United States
facility: PRISM Sports Medicine
state: Connecticut
Study officials:
References:
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