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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

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ClinicalTrials.gov Identifier: NCT04958733
Recruitment Status : Recruiting
First Posted : July 12, 2021
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital

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).


Condition or disease Intervention/treatment Phase
ACL Injury Procedure: Autologous bone grafting Procedure: Absence of autologous bone grafting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : September 3, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Autologous bone grafting
Autologous bone grafting is the excess bone obtained from graft preparation and the coring reamer

Placebo Comparator: Control
The control group will have their patellar and tibial defects remain unfilled.
Procedure: Absence of autologous bone grafting
Donor sites will be left unfilled




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: pre-op ]
    The Visual Analog Scale (VAS) is a 10-cm line that allows subjects to visually report their pain between "no pain" (0 cm) on the left and "constant pain" (10 cm) on the right. Patients will be asked to complete the VAS with the prompt, "Please indicate the amount of pain you are feeling right now in the front of your knee." It is considered a worse outcome the closer the patient marks to the "constant pain" on the right of the scale.

  2. Visual Analog Scale [ Time Frame: post-op month 6 ]
    The Visual Analog Scale (VAS) is a 10-cm line that allows subjects to visually report their pain between "no pain" (0 cm) on the left and "constant pain" (10 cm) on the right. Patients will be asked to complete the VAS with the prompt, "Please indicate the amount of pain you are feeling right now in the front of your knee." It is considered a worse outcome the closer the patient marks to the "constant pain" on the right of the scale.

  3. Visual Analog Scale [ Time Frame: post-op month 12 ]
    The Visual Analog Scale (VAS) is a 10-cm line that allows subjects to visually report their pain between "no pain" (0 cm) on the left and "constant pain" (10 cm) on the right. Patients will be asked to complete the VAS with the prompt, "Please indicate the amount of pain you are feeling right now in the front of your knee." It is considered a worse outcome the closer the patient marks to the "constant pain" on the right of the scale.

  4. Visual Analog Scale [ Time Frame: post-op month 24 ]
    The Visual Analog Scale (VAS) is a 10-cm line that allows subjects to visually report their pain between "no pain" (0 cm) on the left and "constant pain" (10 cm) on the right. Patients will be asked to complete the VAS with the prompt, "Please indicate the amount of pain you are feeling right now in the front of your knee." It is considered a worse outcome the closer the patient marks to the "constant pain" on the right of the scale.

  5. Direct Palpation of Harvest Site [ Time Frame: pre-op ]
    Subjects will be asked to rate their pain as either 'no pain', 'mild pain' or 'sharp pain' during direct palpation for both the patella and tibial harvest sites. 'Sharp pain' is considered the worse outcome, 'mild pain' as a median outcome, and 'no pain' is considered the best outcome of the three.

  6. Direct Palpation of Harvest Site [ Time Frame: post-op month 6 ]
    Subjects will be asked to rate their pain as either 'no pain', 'mild pain' or 'sharp pain' during direct palpation for both the patella and tibial harvest sites. 'Sharp pain' is considered the worse outcome, 'mild pain' as a median outcome, and 'no pain' is considered the best outcome of the three.

  7. Direct Palpation of Harvest Site [ Time Frame: post-op month 12 ]
    Subjects will be asked to rate their pain as either 'no pain', 'mild pain' or 'sharp pain' during direct palpation for both the patella and tibial harvest sites. 'Sharp pain' is considered the worse outcome, 'mild pain' as a median outcome, and 'no pain' is considered the best outcome of the three.

  8. Direct Palpation of Harvest Site [ Time Frame: post-op month 24 ]
    Subjects will be asked to rate their pain as either 'no pain', 'mild pain' or 'sharp pain' during direct palpation for both the patella and tibial harvest sites. 'Sharp pain' is considered the worse outcome, 'mild pain' as a median outcome, and 'no pain' is considered the best outcome of the three.

  9. Pain with Kneeling [ Time Frame: pre-op ]
    Subjects will also be asked to kneel on the floor of the examination room and rate their pain as either 'no pain', 'mild pain', 'unable to kneel on hard surface but able with cushion/pad', or 'complete inability to kneel'. 'Complete inability to kneel' is considered the worst outcome within this measure, with the following considered increasing better outcomes in this order: 'unable to kneel on hard surface but able with cushion/pad', 'mild pain', 'no pain'.

  10. Pain with Kneeling [ Time Frame: post-op month 6 ]
    Subjects will also be asked to kneel on the floor of the examination room and rate their pain as either 'no pain', 'mild pain', 'unable to kneel on hard surface but able with cushion/pad', or 'complete inability to kneel'. 'Complete inability to kneel' is considered the worst outcome within this measure, with the following considered increasing better outcomes in this order: 'unable to kneel on hard surface but able with cushion/pad', 'mild pain', 'no pain'.

  11. Pain with Kneeling [ Time Frame: post-op month 12 ]
    Subjects will also be asked to kneel on the floor of the examination room and rate their pain as either 'no pain', 'mild pain', 'unable to kneel on hard surface but able with cushion/pad', or 'complete inability to kneel'. 'Complete inability to kneel' is considered the worst outcome within this measure, with the following considered increasing better outcomes in this order: 'unable to kneel on hard surface but able with cushion/pad', 'mild pain', 'no pain'.

  12. Pain with Kneeling [ Time Frame: post-op month 24 ]
    Subjects will also be asked to kneel on the floor of the examination room and rate their pain as either 'no pain', 'mild pain', 'unable to kneel on hard surface but able with cushion/pad', or 'complete inability to kneel'. 'Complete inability to kneel' is considered the worst outcome within this measure, with the following considered increasing better outcomes in this order: 'unable to kneel on hard surface but able with cushion/pad', 'mild pain', 'no pain'.


Secondary Outcome Measures :
  1. PROMIS-10 [ Time Frame: pre-op ]
    The Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) will be used to assess global quality of health. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

  2. PROMIS-10 [ Time Frame: post-op month 6 ]
    The Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) will be used to assess global quality of health. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

  3. PROMIS-10 [ Time Frame: post-op month 12 ]
    The Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) will be used to assess global quality of health. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

  4. PROMIS-10 [ Time Frame: post-op month 24 ]
    The Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) will be used to assess global quality of health. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

  5. International Knee Documentation Committee (IKDC) Subjective form [ Time Frame: pre-op ]
    The International Knee Documentation Committee (IKCD) subjective form will be used to assess knee-specific functional abilities. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  6. International Knee Documentation Committee (IKDC) Subjective form [ Time Frame: post-op month 6 ]
    The International Knee Documentation Committee (IKCD) subjective form will be used to assess knee-specific functional abilities. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  7. International Knee Documentation Committee (IKDC) Subjective form [ Time Frame: post-op month 12 ]
    The International Knee Documentation Committee (IKCD) subjective form will be used to assess knee-specific functional abilities. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  8. International Knee Documentation Committee (IKDC) Subjective form [ Time Frame: post-op 24 ]
    The International Knee Documentation Committee (IKCD) subjective form will be used to assess knee-specific functional abilities. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  9. Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF) [ Time Frame: pre-op ]
    The Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF) will be used to assess functional limitations due to patellofemoral joint pain. This will be necessary to evaluate as the BPBT graft is harvested from the patellar and may affect the function of the patellofemoral joint. KOOS-PF is an 11 item patient reported outcome, with each item rated as Never/none = 0, Monthly/mild = 1, Weekly/moderate = 2, Daily/severe = 3, Always/extreme = 4. The mean score is calculated for the 11 items, and divided by the maximum possible score for each item (i.e. 4). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.

  10. Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF) [ Time Frame: post-op month 6 ]
    The Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF) will be used to assess functional limitations due to patellofemoral joint pain. This will be necessary to evaluate as the BPBT graft is harvested from the patellar and may affect the function of the patellofemoral joint. KOOS-PF is an 11 item patient reported outcome, with each item rated as Never/none = 0, Monthly/mild = 1, Weekly/moderate = 2, Daily/severe = 3, Always/extreme = 4. The mean score is calculated for the 11 items, and divided by the maximum possible score for each item (i.e. 4). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.

  11. Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF) [ Time Frame: post-op month 12 ]
    The Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF) will be used to assess functional limitations due to patellofemoral joint pain. This will be necessary to evaluate as the BPBT graft is harvested from the patellar and may affect the function of the patellofemoral joint. KOOS-PF is an 11 item patient reported outcome, with each item rated as Never/none = 0, Monthly/mild = 1, Weekly/moderate = 2, Daily/severe = 3, Always/extreme = 4. The mean score is calculated for the 11 items, and divided by the maximum possible score for each item (i.e. 4). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.

  12. Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF) [ Time Frame: post-op month 24 ]
    The Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain (KOOS-PF) will be used to assess functional limitations due to patellofemoral joint pain. This will be necessary to evaluate as the BPBT graft is harvested from the patellar and may affect the function of the patellofemoral joint. KOOS-PF is an 11 item patient reported outcome, with each item rated as Never/none = 0, Monthly/mild = 1, Weekly/moderate = 2, Daily/severe = 3, Always/extreme = 4. The mean score is calculated for the 11 items, and divided by the maximum possible score for each item (i.e. 4). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.

  13. Marx Activity Scale [ Time Frame: pre-op ]
    The Marx Activity scale will be used to assess frequency and intensity of athletic participation. The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. The maximum score is 16 points, the closer the score is to 16 the higher the intensity and frequency of activity.

  14. Marx Activity Scale [ Time Frame: post-op month 6 ]
    The Marx Activity scale will be used to assess frequency and intensity of athletic participation. The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. The maximum score is 16 points, the closer the score is to 16 the higher the intensity and frequency of activity.

  15. Marx Activity Scale [ Time Frame: post-op month 12 ]
    The Marx Activity scale will be used to assess frequency and intensity of athletic participation. The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. The maximum score is 16 points, the closer the score is to 16 the higher the intensity and frequency of activity.

  16. Marx Activity Scale [ Time Frame: post-op month 24 ]
    The Marx Activity scale will be used to assess frequency and intensity of athletic participation. The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. The maximum score is 16 points, the closer the score is to 16 the higher the intensity and frequency of activity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04958733


Contacts
Layout table for location contacts
Contact: Regina O Kostyun, MSEd 860-972-2657 Regina.Kostyun@hhchealth.org

Locations
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United States, Connecticut
Bone and Joint Institute at Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Regina R Kostyun, MSEd    860-972-2657    Regina.Kostyun@hhchealth.org   
Orthopedic Associates of Hartford Recruiting
Hartford, Connecticut, United States, 06106
Contact: Clifford Rios, MD    860-549-8295    crios@oahctmd.com   
Principal Investigator: Clifford Rios, MD         
Sub-Investigator: J. Kristopher Ware, MD         
PRISM Sports Medicine Recruiting
Hartford, Connecticut, United States, 06106
Contact: Carl Nissen, MD    860-972-6688    Carl.Nissen@hhchealth.org   
Principal Investigator: Carl Nissen, MD         
Sponsors and Collaborators
Hartford Hospital
Publications of Results:

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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT04958733    
Other Study ID Numbers: HHC-2021-0113
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD with other researchers at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries