“Proprietary Processed” Allografts: Clinical Outcomes and Biomechanical Properties in Anterior Cruciate Ligament Reconstruction

Roberson, Troy A.; Abildgaard, Jeffrey T.; Wyland, Douglas J.; Siffri, Paul; Geary, Stephen; Hawkins, Richard J.; Tokish, John M.

doi:10.1177/0363546516687540

Cited by 9 publications

(10 citation statements)

References 48 publications

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“…The allografts in this study were predominantly fresh frozen, without proprietary processing, and were nonirradiated or irradiated <2.5 mRad. In a systematic review by Roberson et al, 39 it was noted that comparing allograft processing techniques is difficult owing to differences in the various methods and lack of pertinent details when reported in the literature. Nevertheless, the results of our study should be considered when choosing an ACL graft source for patients who have repairable meniscal tears at the time of ACLR, as allografts may lead to an increased risk of meniscal repair failure.…”

Section: Discussionmentioning

confidence: 99%

Anterior Cruciate Ligament Reconstruction With Concomitant Meniscal Repair: Is Graft Choice Predictive of Meniscal Repair Success?

Salem

Huston

Zajichek

et al. 2021

Orthopaedic Journal of Sports Medicine

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Background: When meniscal repair is performed during anterior cruciate ligament (ACL) reconstruction (ACLR), the effect of ACL graft type on meniscal repair outcomes is unclear. Hypothesis: The authors hypothesized that meniscal repairs would fail at the lowest rate when concomitant ACLR was performed with bone--patellar tendon--bone (BTB) autograft. Study Design: Cohort study; Level of evidence, 3. Methods: Patients who underwent meniscal repair at primary ACLR were identified from a longitudinal, prospective cohort. Meniscal repair failures, defined as any subsequent surgical procedure addressing the meniscus, were identified. A logistic regression model was built to assess the association of graft type, patient-specific factors, baseline Marx activity rating score, and meniscal repair location (medial or lateral) with repair failure at 6-year follow-up. Results: A total of 646 patients were included. Grafts used included BTB autograft (55.7%), soft tissue autograft (33.9%), and various allografts (10.4%). We identified 101 patients (15.6%) with a documented meniscal repair failure. Failure occurred in 74 of 420 (17.6%) isolated medial meniscal repairs, 15 of 187 (8%) isolated lateral meniscal repairs, and 12 of 39 (30.7%) of combined medial and lateral meniscal repairs. Meniscal repair failure occurred in 13.9% of patients with BTB autografts, 17.4% of patients with soft tissue autografts, and 19.4% of patients with allografts. The odds of failure within 6 years of index surgery were increased more than 2-fold with allograft versus BTB autograft (odds ratio = 2.34 [95% confidence interval, 1.12-4.92]; P = .02). There was a trend toward increased meniscal repair failures with soft tissue versus BTB autografts (odds ratio = 1.41 [95% confidence interval, 0.87-2.30]; P = .17). The odds of failure were 68% higher with medial versus lateral repairs ( P < .001). There was a significant relationship between baseline Marx activity level and the risk of subsequent meniscal repair failure; patients with either very low (0-1 points) or very high (15-16 points) baseline activity levels were at the highest risk ( P = .004). Conclusion: Meniscal repair location (medial vs lateral) and baseline activity level were the main drivers of meniscal repair outcomes. Graft type was ranked third, demonstrating that meniscal repairs performed with allograft were 2.3 times more likely to fail compared with BTB autograft. There was no significant difference in failure rates between BTB versus soft tissue autografts. Registration: NCT00463099 (ClinicalTrials.gov identifier).

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Section: Discussionmentioning

confidence: 99%

Anterior Cruciate Ligament Reconstruction With Concomitant Meniscal Repair: Is Graft Choice Predictive of Meniscal Repair Success?

Salem

Huston

Zajichek

et al. 2021

Orthopaedic Journal of Sports Medicine

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“…Roberson et al [101] also studied the effect of such processing analysing the results from 13 clinical, and 11 biomechanical studies in 2017. At time zero, there were no biomechanical differences and clinical failure rates were similar (BioCleanse: 5.4%; AlloTrue: 5.7%; MTF: 6.7%).…”

Section: Introductionmentioning

confidence: 99%

“…The authors noted that the sole BioCleanse clinical study demonstrated excellent clinical outcomes, but the study received scrutiny for being industry sponsored and the fact that 42% of patients were lost to follow‐up. Two other important points were made in this paper: first that reporting of graft processing is not clearly described in many papers making analysis difficult and that the use of ‘low dose’ or ‘terminal radiation’ for what are thought to be non‐irradiated grafts is unclear and variable, also making analysis difficult [101].…”

Section: Introductionmentioning

confidence: 99%

The use of allograft tendons in primary ACL reconstruction

Hulet

Sonnery‐Cottet

Stevenson

et al. 2019

Knee Surg Sports Traumatol Arthrosc

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Purpose Graft choice in primary anterior cruciate ligament (ACL) reconstruction remains controversial. The use of allograft has risen exponentially in recent years with the attraction of absent donor site morbidity, reduced surgical time and reliable graft size. However, the published evidence examining their clinical effectiveness over autograft tendons has been unclear. The aim of this paper is to provide a current review of the clinical evidence available to help guide surgeons through the decision-making process for the use of allografts in primary ACL reconstruction. Methods The literature in relation to allograft healing, storage, sterilisation, differences in surgical technique and rehabilitation have been reviewed in addition to recent comparative studies and all clinical systematic reviews and meta-analyses. Results Early reviews have indicated a higher risk of failure with allografts due to association with irradiation for sterilisation and where rehabilitation programs and post-operative loading may ignore the slower incorporation of allografts. More recent analysis indicates a similar low failure rate for allograft and autograft methods of reconstruction when using non-irradiated allografts that have not undergone chemically processing and where rehabilitation has been slower. However, inferior outcomes with allografts have been reported in young (< 25 years) highly active patients, and also when irradiated or chemically processed grafts are used. Conclusion When considering use of allografts in primary ACL reconstruction, use of irradiation, chemical processing and rehabilitation programs suited to autograft are important negative factors. Allografts, when used for primary ACL reconstruction, should be fresh frozen and non-irradiated. Quantification of the risk of use of allograft in the young requires further evaluation. Levels of evidence III. Keywords Anterior cruciate ligament reconstruction • Allografts • ACL • Graft choice • Decision making • AutograftsThis work performed as part of the ESSKA Arthroscopy Committee.

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“… 23 BioCleanse is one chemical-processing method that has been reported to have no detrimental effects on preimplantation biomechanical properties strength and used in this study. 24 , 25 …”

Section: Discussionmentioning

confidence: 99%

A Prospective, Double-Blind Evaluation of Anterior Cruciate Ligament Reconstruction With Tibialis Tendon Allograft: Donor Age Does Not Alter Outcomes

Carter¹,

Norton²

2023

Arthroscopy, Sports Medicine, and Rehabilitation

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“Proprietary Processed” Allografts: Clinical Outcomes and Biomechanical Properties in Anterior Cruciate Ligament Reconstruction

Cited by 9 publications

References 48 publications

Anterior Cruciate Ligament Reconstruction With Concomitant Meniscal Repair: Is Graft Choice Predictive of Meniscal Repair Success?

Anterior Cruciate Ligament Reconstruction With Concomitant Meniscal Repair: Is Graft Choice Predictive of Meniscal Repair Success?

The use of allograft tendons in primary ACL reconstruction

A Prospective, Double-Blind Evaluation of Anterior Cruciate Ligament Reconstruction With Tibialis Tendon Allograft: Donor Age Does Not Alter Outcomes

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