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 | Unknown

• 1 other identifier: HHC-2021-0113
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (12)

• Visual Analog Scale

  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.

  pre-op

• Visual Analog Scale

  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.

  post-op month 6

• Visual Analog Scale

  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.

  post-op month 12

• Visual Analog Scale

  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.

  post-op month 24

• Direct Palpation of Harvest Site

  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.

  pre-op

• Direct Palpation of Harvest Site

  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.

  post-op month 6

• Direct Palpation of Harvest Site

  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.

  post-op month 12

• Direct Palpation of Harvest Site

  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.

  post-op month 24

• Pain with Kneeling

  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'.

  pre-op

• Pain with Kneeling

  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'.

  post-op month 6

• Pain with Kneeling

  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'.

  post-op month 12

• Pain with Kneeling

  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'.

  post-op month 24

Secondary Outcomes (16)

• PROMIS-10

  pre-op

• PROMIS-10

  post-op month 6

• PROMIS-10

  post-op month 12

• PROMIS-10

  post-op month 24

• International Knee Documentation Committee (IKDC) Subjective form

  pre-op

Study Arms (2)

Autologous Bone Grafting

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Procedure: Absence of autologous bone grafting

Interventions

Autologous bone grafting PROCEDURE

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

Autologous Bone Grafting

Absence of autologous bone grafting PROCEDURE

Donor sites will be left unfilled

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (3)

Bone and Joint Institute at Hartford Hospital

Hartford, Connecticut, 06106, United States

RECRUITING

Orthopedic Associates of Hartford

Hartford, Connecticut, 06106, United States

RECRUITING

PRISM Sports Medicine

Hartford, Connecticut, 06106, United States

RECRUITING

Related Publications (10)

• Ahn JH, Kim JG, Wang JH, Jung CH, Lim HC. Long-term results of anterior cruciate ligament reconstruction using bone-patellar tendon-bone: an analysis of the factors affecting the development of osteoarthritis. Arthroscopy. 2012 Aug;28(8):1114-23. doi: 10.1016/j.arthro.2011.12.019. Epub 2012 Mar 13.

  PMID: 22421565 RESULT

• Brown K, Solomon MJ, Young J, Seco M, Bannon PG. Addressing the ethical grey zone in surgery: a framework for identification and safe introduction of novel surgical techniques and procedures. ANZ J Surg. 2019 Jun;89(6):634-638. doi: 10.1111/ans.15104. Epub 2019 Apr 11.

  PMID: 30974516 RESULT

• Brydone AS, Meek D, Maclaine S. Bone grafting, orthopaedic biomaterials, and the clinical need for bone engineering. Proc Inst Mech Eng H. 2010 Dec;224(12):1329-43. doi: 10.1243/09544119JEIM770.

  PMID: 21287823 RESULT

• Cervellin M, de Girolamo L, Bait C, Denti M, Volpi P. Autologous platelet-rich plasma gel to reduce donor-site morbidity after patellar tendon graft harvesting for anterior cruciate ligament reconstruction: a randomized, controlled clinical study. Knee Surg Sports Traumatol Arthrosc. 2012 Jan;20(1):114-20. doi: 10.1007/s00167-011-1570-5. Epub 2011 Jun 16.

  PMID: 21678095 RESULT

• Kartus J, Stener S, Lindahl S, Engstrom B, Eriksson BI, Karlsson J. Factors affecting donor-site morbidity after anterior cruciate ligament reconstruction using bone-patellar tendon-bone autografts. Knee Surg Sports Traumatol Arthrosc. 1997;5(4):222-8. doi: 10.1007/s001670050054.

  PMID: 9430571 RESULT

• Leathers MP, Merz A, Wong J, Scott T, Wang JC, Hame SL. Trends and Demographics in Anterior Cruciate Ligament Reconstruction in the United States. J Knee Surg. 2015 Oct;28(5):390-4. doi: 10.1055/s-0035-1544193. Epub 2015 Jan 30.

  PMID: 25635874 RESULT

• Mastrokalos DS, Springer J, Siebold R, Paessler HH. Donor site morbidity and return to the preinjury activity level after anterior cruciate ligament reconstruction using ipsilateral and contralateral patellar tendon autograft: a retrospective, nonrandomized study. Am J Sports Med. 2005 Jan;33(1):85-93. doi: 10.1177/0363546504265926.

  PMID: 15611003 RESULT

• Schandl K, Horvathy DB, Doros A, Majzik E, Schwarz CM, Csonge L, Abkarovits G, Bucsi L, Lacza Z. Bone-Albumin filling decreases donor site morbidity and enhances bone formation after anterior cruciate ligament reconstruction with bone-patellar tendon-bone autografts. Int Orthop. 2016 Oct;40(10):2097-2104. doi: 10.1007/s00264-016-3246-8. Epub 2016 Jun 29.

  PMID: 27357530 RESULT

• Walters BL, Porter DA, Hobart SJ, Bedford BB, Hogan DE, McHugh MM, Klein DA, Harousseau K, Nicholas SJ. Effect of Intraoperative Platelet-Rich Plasma Treatment on Postoperative Donor Site Knee Pain in Patellar Tendon Autograft Anterior Cruciate Ligament Reconstruction: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2018 Jul;46(8):1827-1835. doi: 10.1177/0363546518769295. Epub 2018 May 9.

  PMID: 29741923 RESULT

• Xie X, Liu X, Chen Z, Yu Y, Peng S, Li Q. A meta-analysis of bone-patellar tendon-bone autograft versus four-strand hamstring tendon autograft for anterior cruciate ligament reconstruction. Knee. 2015 Mar;22(2):100-10. doi: 10.1016/j.knee.2014.11.014. Epub 2014 Dec 11.

  PMID: 25547048 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Regina O Kostyun, MSEd

CONTACT

860-972-2657; Regina.Kostyun@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 12, 2021
• Study Start: September 3, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)