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Abstract

Background:

Emerging research suggests that immune responses may influence results after various orthopaedic operations. This study aimed to determine if similar relationships exist in meniscal allograft transplantation (MAT).

Purpose:

To compare clinical outcomes and failure rates for patients who underwent MAT based on presence or absence of self-reported drug allergies.

Study Design:

Cohort study; Level of evidence, 3.

Methods:

A retrospective review of patients who underwent MAT from January 2004 to December 2021 at a single academic medical institution was conducted with minimum follow-up of 2 years. Age, sex, body mass index, and presence of concomitant procedures were collected. The presence or absence of patient-reported allergies was recorded from the electronic medical record. Graft failure was defined as removal or revision of primary MAT, subsequent cartilage procedure, or progression to arthroplasty. The Lysholm score, International Knee Documentation Committee (IKDC) score, and all Knee injury and Osteoarthritis Outcome Score (KOOS) were compared for each patient from preoperative to 2-year time points. The minimal clinically important difference was determined using distribution-based method.

Results:

A total of 107 patients who underwent MAT with minimum follow-up of 2 years were included in the study. Of the total, 22 (20.6%) had self-reported ≥1 medication allergy and 85 (79.4%) did not report any medication allergies. There were no significant differences between the no-allergy and allergy cohorts in other demographic variables. There was no significant difference in failure rate between the no-allergy and allergy cohorts (18.1% vs 8.2%; P = .17). There were no statistically significant differences in Lysholm, IKDC, or KOOS subscales preoperatively or at 2 years postoperatively. Self-reported drug allergies did not serve as a significant risk factor for failing to achieve minimal clinically important difference across any outcomes in the patient population.

Conclusion:

The presence of self-reported drug allergies does not appear to adversely affect clinically significant outcome improvement or graft survival rates in patients undergoing MAT. These findings suggest that self-reported allergies should not be considered a limiting factor for MAT and that surgeons can continue to focus on other patient-specific factors that may be more predictive of postoperative outcomes.

Keywords

meniscal allograft transplantation immune hypersensitivity graft failure clinically significant outcome improvement

Meniscal allograft transplantation (MAT) has been performed for >2 decades as a treatment strategy to reduce symptoms, restore load-bearing capacity, and provide chondroprotective effects in patients with meniscal deficiency.^13,25 Although MAT has shown promise in improving pain and function, long-term outcomes studies continue to reveal variability in outcomes.^18,22,27,29 Therefore, it is essential to identify patient-specific prognostic factors that influence postoperative outcomes as well as those at risk for poor results to enhance patient selection and optimize long-term success. Establishing tailored prognostic information will help refine MAT indications and improve overall surgical outcomes, ensuring the best possible intervention for each patient.

Multiple types of grafts that can be used in MAT, and their sterilization and preparation techniques can effect graft viability, immunogenicity, and biomechanical properties.¹⁵ Of the options available, deep-frozen and lyophilized grafts are considered less immunogenic because the freezing and drying processes reduce the viability of donor cells.^2,15 However, these processes affect the grafts’ biomechanical properties and compromise their structural integrity.^3,6 Meniscal allografts have been shown to express class I and class II histocompatibility antigens, especially bone that remains attached to the graft; both of these factors can potentially trigger an immune response.^11,12,15 While MAT does not require postoperative immunosuppression, there has been conflicting evidence on whether or not the recipient’s immune response could have an effect on clinical outcomes after transplantation.^8,28

Multiple studies in the orthopaedic literature have demonstrated that patients who self-report drug allergies may have poorer postoperative outcomes, with outcomes generally shown to be negatively correlated with an increasing number of reported allergies. This has been hypothesized to be in part due to an increased immune response. Studies have demonstrated increased failure rates, postoperative infection, and worse postoperative functional outcomes in those reporting allergies after osteochondral allograft transplantation,¹⁶ hip arthroscopy,²⁶ and multiple types of arthroplasty.^{5,10,14,19,20} To our knowledge, however, no studies have yet investigated how a patient’s self-reported allergies affect outcomes after MAT.

The purpose of the current study was to compare clinical outcomes and failure rate for patients who underwent MAT based on the presence or absence of self-reported drug allergies. The authors hypothesized that patients with ≥1 self-reported allergy would have worse patient-reported outcomes and failure rates after MAT compared with patients who did not report having an allergy.

Methods

Patient Selection

Institutional review board approval was obtained before commencing study activities. A retrospective review was conducted using a prospectively created database of patients who underwent an MAT procedure from January 2004 to December 2021 at a single academic medical institution. All patients who underwent unilateral MAT and had follow-up data specifically at 2 years were included, with additional data collected up to their longest available follow-up.

Surgical Technique

Each patient had been treated by the senior author (B.J.C.) using the bridge-in-slot technique for medial and lateral MATs with fresh-frozen, nonirradiated meniscal grafts (JRF Ortho); and, if present, concomitant pathology such as malalignment, focal cartilage defects, or ligamentous insufficiency were treated as well.^7,21,24 Before transplantation, the meniscus was evaluated alongside the anterior and posterior cruciate ligaments as well as the chondral surfaces of the medial, lateral, and patellofemoral compartments. The meniscus underwent debridement leaving a bleeding peripheral rim of about 1 to 2 mm and the anterior and posterior horns were subsequently removed. For preparing the meniscal slot, an initial slot guide was created using a 4.5-mm bur followed by the insertion of a guide pin. The guide pin was then overreamed with a 7-mm reamer and the slot was further refined with the use of a box cutter, dilating rasp, and bone-cutting shaver.

During the preparation of the tibial slot, the meniscal allograft was thawed in normal saline on a sterile surgical table. Once adequately thawed, a bone bridge was fashioned using a reciprocating saw between the anterior and posterior horns of the donor meniscus. A polydioxanone suture was threaded through the posterior third of the meniscus to facilitate insertion into the joint and, subsequently, the tibial slot. With the knee placed in flexion, a 7 × 23–mm bioabsorbable interference screw was employed to secure the bone bridge within the tibial tunnel. The meniscus was then fixed in place using approximately 8 to 10 nonabsorbable 2-0 ultra–high molecular weight vertical mattress sutures with an inside-out technique. After verification of proper meniscal placement and stability the incisions were closed in the usual manner.

Data Collection

Patient demographic data including age, sex, and body mass index (BMI) were collected. The presence or absence of patient-reported allergies were also recorded from the electronic medical record. Concomitant procedures including distal femoral osteotomy, osteochondral allograft transplantation, anterior cruciate ligament reconstruction, and additional cartilage procedures such as autologous chondrocyte implantation and osteochondral autograft transplantation were recorded. Medical history including reoperation rate and failure were gathered as well. Graft failure was defined as removal or revision of primary MAT, subsequent cartilage procedure (chondroplasty, microfracture, meniscectomy, etc), or progression to any form of arthroplasty.

Clinical Outcomes

The Lysholm score, International Knee Documentation Committee (IKDC) score, and all Knee injury and Osteoarthritis Outcome Score (KOOS) subscales—Pain, Symptoms, Activities of Daily Living (ADL), Sport and Recreation (Sport/Rec), and Quality of Life (QOL)—were compared for each patient from the preoperative to the 2-year time points. Additionally, the minimal clinically important difference (MCID) for these outcomes was determined using the distribution-based method with the MCID threshold set at half the standard deviation of the mean change in outcome scores from the preoperative period to the 2-year postoperative time point.⁴ Following this calculation, the MCID thresholds for our specific patient population were determined to be a change of 10.56 points for the Lysholm, 10.76 points for IKDC, 10.78 points for KOOS Pain, 9.12 points for KOOS Symptoms, 9.38 points for the KOOS ADL, 15.25 points for KOOS Sport/Rec, and 12.68 points for KOOS QOL.

Statistical Analysis

Patients were separated into 2 groups: those with ≥1 reported medication allergy (allergy group) and those with no reported medication allergies (no-allergy group), and their outcomes were compared. Baseline demographic data were described with mean and standard deviation for continuous variables and frequency with percentage for discrete data. Student t tests were used to compare continuous demographic variables and patient-reported outcome measures at baseline and at 2 years. Pearson chi-square test of independence, or when frequencies were appropriately small, Fisher exact test, was used to compare discrete demographic variables, rates of clinically significant outcome improvement, rates of failure, and concomitant procedures. Statistical analysis was performed using Microsoft Excel (Version 2308; Microsoft Corp).

Results

Patient Demographics

A total of 107 patients who underwent MAT with a minimum follow-up of 2 years were included in the study. Of these patients, 22 (20.6%) had self-reported ≥1 medication allergy and 85 (79.4%) did not report any medication allergies. There were no significant differences between the no-allergy and allergy cohorts with respect to age (28.62 ± 11.07 vs 26.63 ± 6.91; P = .30), BMI (25.30 ± 3.57 vs 25.27 ± 6.34; P = .98), follow-up years (5.18 ± 4.38 vs 4.79 ± 3.92; P = .29), and sex (50.6% vs 59.1% female; P = .42) as demonstrated in Table 1.

Table 1

Baseline Characteristics of Cohorts Differentiated by Self-Reported Allergy Status ^a

Characteristic	No Allergies (n = 85)	Allergies (n = 22)	All (N = 107)	P
Age, y	28.62 ± 11.07	26.63 ± 6.91	28.21 ± 10.36	.30 ^b
Body mass index, kg/m²	25.30 ± 3.57	25.27 ± 6.34	25.30 ± 4.27	.98 ^b
Follow-up, y	5.18 ± 4.38	4.79 ± 3.92	5.10 ± 4.27	.29 ^b
Sex
Female	43 (50.6)	13 (59.1)	55 (51.4)	.42 ^c
Male	42 (49.4)	9 (40.9)	52 (48.6)	.42 ^c

Data are presented as mean ± SD or n (%).

Student t test.

Pearson chi-square test.

The frequency of concomitant procedures was compared between the allergy and no-allergy cohorts and is summarized in Table 2. There were no differences between the cohorts for any of these procedures.

Table 2

Concomitant Procedures of Cohorts Differentiated by Self-Reported Allergy Status ^a

Procedure	No Allergies (n = 85)	Allergies (n = 22)	All (N = 107)	P
DFO	4	3	7	.15 ^b
OCA	39	11	50	.73 ^c
ACLR	9	2	11	≥.99 ^b
ACI	10	1	11	.45 ^b
MFx	6	1	7	≥.99 ^b
OAT	3	0	3	≥.99 ^b

Data are presented as No. ACI, autologous chondrocyte implantation; ACLR, anterior cruciate ligament reconstruction; DFO, distal femoral osteotomy; MFx, microfracture; OAT, osteochondral autograft transplantation.

Fisher exact test.

Pearson chi-square test.

Graft Failure

Graft failure defined as removal or revision of primary MAT, subsequent cartilage procedure (chondroplasty, microfracture, meniscectomy, etc) or progression to any form of arthroplasty occurred in 9.3% of the total patient population. There was no significant difference in failure rate between the no-allergy and allergy cohorts (18.1% vs 8.2%; P = .17).

Clinical and Functional Outcome Analysis

At baseline, no statistically significant differences were observed in the preoperative setting between the no-allergy cohort and the allergy cohort in Lysholm (46.23 ± 19.0 vs 29.75 ± 12.69; P = .07), IKDC (43.23 ± 15.81 vs 35.20 ± 18.63; P = .13), KOOS Pain (58.48 ± 16.78 vs 53.01 ± 19.15; P = .37), KOOS Symptoms (57.34 ± 17.71 vs 52.96 ± 18.90; P = .49), KOOS ADL (72.51 ± 18.86 vs 63.77 ± 19.55; P = .19), KOOS Sport/Rec (33.49 ± 23.16 vs 27.27 ± 22.29; P = .42), and KOOS QOL (26.78 ± 16.47 vs 19.27 ± 17.97; P = .20).

Similarly, no statistically significant differences were found between the cohorts at 2 years postoperatively. The 2-year follow-up patient-reported outcome comparison between the cohorts is shown in Table 3.

Table 3

Comparison of Postoperative Patient-Reported Outcome Measures Between Patients With and Without Self-Reported Allergies ^a

Postoperative Outcome	No Allergies (n = 85)	Allergies (n = 22)	All (N = 107)	P ^b
Lysholm	65.74 ± 25.08	70.57 ± 24.09	66.30 ± 24.82	.63
IKDC	62.93 ± 20.46	64.78 ± 22.15	63.32 ± 20.73	.73
KOOS Pain	74.20 ± 19.60	80.90 ± 12.90	75.40 ± 18.69	.10
KOOS Symptoms	72.73 ± 18.63	77.46 ± 13.15	73.59 ± 17.79	.24
KOOS ADL	88.80 ± 14.42	88.33 ± 12.08	88.71 ± 13.95	.89
KOOS Sport/Rec	55.25 ± 26.24	60.31 ± 25.46	56.15 ± 26.04	.48
KOOS QOL	48.90 ± 25.30	57.81 ± 18.61	50.48 ± 24.39	.12

Data are presented as mean ± SD. ADL, Activities of Daily Living; IKDC, International Knee Documentation Committee; KOOS, Knee injury and Osteoarthritis Outcome Score; QOL, Quality of Life; Sport/Rec, Sport and Recreation.

Student t test.

Clinically Significant Outcome Improvement

The likelihood of achieving clinically significant outcome improvement, as measured by the rate of reaching the MCID at a minimum of 2 years after MAT, was assessed and compared. Quantitative comparisons of the MCID across different stratifications are presented in Table 4. The analysis revealed that self-reported drug allergies did not serve as a significant risk factor for failing to achieve clinically significant outcome improvement across any of the measured outcomes in this patient population.

Table 4

Comparison of Rates of Clinically Significant Outcome Improvement at 2 Years After Meniscal Allograft Transplantation Between Patients With and Without Self-Reported Allergies ^a

MCID	No Allergies (n = 85)	Allergies (n = 22)	All (N = 107)	P ^b
Lysholm	73	67	72	.82
IKDC	64	60	63	.80
KOOS Pain	56	82	61	.11
KOOS Symptoms	63	80	65	.27
KOOS ADL	57	70	59	.47
KOOS Sport/Rec	50	60	52	.50
KOOS QOL	61	73	63	.45

Data are presented as percentages. ADL, Activities of Daily Living; IKDC, International Knee Documentation Committee; KOOS, Knee injury and Osteoarthritis Outcome Score; MCID, minimal clinically important difference; QOL, Quality of Life; Sport/Rec, Sport and Recreation.

Student t test.

Discussion

Contrary to our hypothesis, the main finding of our study demonstrated that the presence of self-reported drug allergies was not associated with worse outcomes or higher failure rates at a minimum follow-up of 2 years. Previous studies have demonstrated that other patient demographic factors, such as age, sex, and BMI, have prognostic information on outcomes after MAT, which does not appear to be the case for patient-reported allergies. Unlike other orthopaedic procedures where self-reported allergies have been linked to poorer outcomes, MAT outcomes are not significantly influenced by patients’ allergy status.

Our study adds to the growing body of literature on the possible role of immune response in musculoskeletal procedures. A multitude of studies have highlighted the negative association between self-reported allergies and clinical outcomes in numerous orthopaedic procedures. Graves et al¹⁰ found that patients with multiple reported allergies experienced significantly lower functional outcomes and less improvement after total hip and knee arthroplasty, while Fisher et al⁵ demonstrated that an increased number of self-reported drug allergies was associated with a higher risk of periprosthetic joint infections after these joint replacement procedures, indicating that such patients may require additional preventive measures. Importantly, arthroplasty procedures involve the implantation of a large amount of metal, which may elicit an allergic reaction in susceptible patients and further contribute to poorer outcomes. Similarly, in a single institution retrospective study, Morgan et al¹⁷ demonstrated that the presence of patient-reported allergies was significantly associated with the diagnosis of postoperative adhesive capsulitis after arthroscopic rotator cuff repairs. Notably, many of these previous studies demonstrate that worse outcomes are correlated with an increasing number of self-reported drug allergies, highlighting the relevance of this factor in the context of other orthopaedic procedures.

Procedures utilizing grafts have shown mixed results regarding the effect of patient-reported allergies. Wright-Chisem et al³⁰ explored the effect of drug allergies on outcomes in osteochondral allograft and found no significant association between drug allergies and achieving clinically significant postoperative improvements. Similarly, Moore et al¹⁶ examined the relationship between allergies and osteochondral allograft outcomes, finding no significant differences in patient-reported outcomes between those with and without allergies. However, they identified that the presence of ≥1 reported allergy was associated with graft failure, suggesting that while allergies may not play a clinically significant role in MAT outcomes, immune hypersensitivity could negatively affect histologic graft incorporation. Finally, Bi et al¹ investigated the effect of immune hypersensitivity on medial patellofemoral reconstruction outcomes and found no evidence of decreased postoperative pain, functional outcomes, or satisfaction between patients with reported allergies and those without, similar to the findings of the present study.

As discussed, while immune hypersensitivity and self-reported drug allergies have been associated with adverse outcomes in procedures such as total knee arthroplasty, hip arthroscopy, and osteochondral allograft transplantation, this relationship did not hold true in our MAT cohort. One possible explanation for this discrepancy is that the immunogenicity of meniscal allografts, especially when using fresh-frozen, nonirradiated grafts, may be sufficiently low, reducing the likelihood of an immune-mediated response that could affect clinical outcomes. Additionally, the lack of significant metal implantation in our MAT technique may further mitigate the risk of allergic or hypersensitivity reactions, which are more commonly observed in procedures involving substantial metal components. Furthermore, the lack of significant differences in the achievement of the MCID between patients with and without self-reported allergies suggests that MAT can provide meaningful improvements in pain and function regardless of allergy status.

The overall graft failure rate observed in this study was 9.3% at a mean follow-up of 5.1 years, which is consistent with previous literature. Grassi et al⁹ reported a graft failure rate of 10.8% at a mean follow-up of 5.7 years and Song et al²³ reported a graft failure rate of 9.5% at a mean of 5.0 years follow-up in similar demographic cohorts to our study. This finding aligns with the hypothesis that while certain aspects of immune response may play a role in graft survival, the presence of self-reported drug allergies alone is not a major determinant of graft failure in MAT.

Limitations

This study has numerous limitations to consider. The retrospective design may introduce selection bias, and the reliance on self-reported allergies could result in misclassification or incomplete reporting. Additionally, the sample size, particularly in the allergy cohort, was relatively small, potentially limiting the power to detect more subtle differences between groups. However, given that the graft failure rate was 18.1% in the patients without allergies and 8.2% in those with allergies, it is unlikely that even with larger sample sizes, our hypothesis that patients with allergies would have higher failure rates would have been true. Another limitation is that we did not investigate the number of drug allergies as a potential risk factor for outcomes. Previous studies have suggested a correlation between an increasing number of reported allergies and worse outcomes, which should be explored in future research. Future studies with larger sample sizes and prospective designs are warranted to validate these findings and further explore the role of immune response in MAT outcomes.

It is also important to acknowledge that some patients with self-reported drug allergies may not be experiencing true immunoglobulin E (IgE)–mediated hypersensitivity. An IgE-mediated response typically involves an immediate allergic reaction, such as anaphylaxis or urticaria, where the immune system reacts to a specific allergen. In contrast, adverse reactions may encompass a broader range of non–immune mediated responses, such as side effects or intolerance to a medication that do not involve an allergic mechanism. Many individuals might report allergies to various drugs without having an actual allergic response, leading to potential misclassification.

Moreover, patients with self-reported allergies could have underlying psychiatric conditions, such as anxiety or depression, which might influence their perception of medications and their experiences with side effects. These conditions can lead to heightened sensitivity to bodily sensations and a more negative outlook on health matters, potentially increasing the likelihood of reporting drug allergies. This uncertainty regarding the nature of self-reported allergies highlights the need for more detailed assessments in future research to better elucidate the relationship between immune responses and clinical outcomes.

Conclusion

The presence of self-reported drug allergies does not appear to adversely affect clinically significant outcome improvement or graft survival rates in patients undergoing MAT. These findings suggest that self-reported allergies should not be considered a limiting factor for MAT, and surgeons can continue to focus on other patient-specific factors that may be more predictive of postoperative outcomes.

Footnotes

Final revision submitted February 18, 2025; accepted March 4, 2025.

One or more of the authors has declared the following potential conflict of interest or source of funding: B.J.C. has received research support from Aesculap/B.Braun, Arthrex Inc, MediPost, and National Institutes of Health (National Institute of Arthritis and Musculoskeletal and Skin Diseases and National Institute of Child Health and Human Development); paid consultant for Arthrex Inc, Ossio, Pacira Pharmaceuticals, Vericel, Bioventus, Acument LLC, DJO LLC, Anika Therapeutics, Endo Pharmaceuticals Inc, and Flexion Therapeutics Inc; financial or material support from Elsevier Publishing and JRF Ortho; support for education from Endo Pharmaceuticals Inc and Medwest Associates; hospitality payments from GE Healthcare; and speaking fees from Terumo BCT Inc. B.J.C. receives IP royalties from Arthrex Inc and Elsevier Publishing and has stock or stock options in Bandgrip Inc and Ossio. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.

Ethical approval for this study was obtained from Rush University Medical Center (ORA No. 24070703-IRB01).

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Does Self-Reported Drug Allergy Influence Clinically Significant Outcome Improvement and Graft Failure Rates After Meniscal Allograft Transplantation of the Knee?

Abstract

Background:

Purpose:

Study Design:

Methods:

Results:

Conclusion:

Keywords

Methods

Patient Selection

Surgical Technique

Data Collection

Clinical Outcomes

Statistical Analysis

Results

Patient Demographics

Graft Failure

Clinical and Functional Outcome Analysis

Clinically Significant Outcome Improvement

Discussion

Limitations

Conclusion

Footnotes

References