|Year : 2022 | Volume
| Issue : 1 | Page : 38-41
The safety and efficacy of biceps tenodesis performed using a novel suture anchor
Andrea H Johnson, M Brook Fowler, Michaline West, Justin J Turcotte, Daniel E Redziniak
Anne Arundel Medical Center, Annapolis, MD, USA
|Date of Submission||07-Sep-2021|
|Date of Acceptance||25-Dec-2021|
|Date of Web Publication||15-Jun-2022|
Dr. Justin J Turcotte
2000 Medical Parkway, Suite 503, Annapolis, MD 21401
Source of Support: None, Conflict of Interest: None
Introduction: Biceps tendon degeneration or tearing is a significant cause of shoulder discomfort and dysfunction. Biceps tenodesis is commonly performed to treat symptomatic biceps tendon pathology. A variety of fixation techniques can be used including screw fixation, endobutton, or suture anchor techniques. This study examines the patient outcomes when the FOOTPRINT™ Ultra suture anchor system is used for biceps tenodesis. Materials and Methods: Retrospective review of consecutive patients undergoing biceps tenodesis was conducted. All patients underwent biceps tenodesis using the FOOTPRINT™ Ultra suture anchor. The primary endpoint was any device-related complication during the intraoperative or postoperative period. Descriptive and inferential statistics were performed to assess patient characteristics and outcomes. Results: Twenty-nine patients were included in this study; 20 (69.0%) underwent arthroscopic biceps tenodesis and the remainder underwent open surgery. The mean follow-up time was 8.51 ± 5.28 months postoperatively. One patient experienced a postoperative infection within the first 30 days requiring a return to the operating room. Two patients experienced a complication within the first 6 months postoperatively. No patients experienced a device-related complication. No patients experienced a retear of their biceps tendon; two patients experienced a retear to their rotator cuff repair. The mean pain Numeric Rating Scale improved from 5.88 ± 2.58 on a scale of 0–10 preoperatively to 1.94 ± 2.32 postoperatively (P < 0.001). Conclusion: The FOOTPRINT™ Ultra suture anchor appears to be safe for the use in patients undergoing arthroscopic or open biceps tenodesis.
Keywords: Arthroscopic biceps tenodesis, open biceps tenodesis, suture anchor
|How to cite this article:|
Johnson AH, Fowler M B, West M, Turcotte JJ, Redziniak DE. The safety and efficacy of biceps tenodesis performed using a novel suture anchor. J Orthop Traumatol Rehabil 2022;14:38-41
|How to cite this URL:|
Johnson AH, Fowler M B, West M, Turcotte JJ, Redziniak DE. The safety and efficacy of biceps tenodesis performed using a novel suture anchor. J Orthop Traumatol Rehabil [serial online] 2022 [cited 2022 Jun 26];14:38-41. Available from: https://www.jotr.in/text.asp?2022/14/1/38/347376
| Introduction|| |
The long head of the biceps tendon (LHBT) disorders is a common cause of anterior shoulder pain and can result in significant functional impairment of affected patients., Conventionally, the associated tendinopathy is first treated with conservative measures including activity modification, physical therapy, nonsteroidal anti-inflammatory drugs, and steroid injections; if symptoms persist, surgical intervention may be indicated. Surgical intervention includes both arthroscopic and open procedures including biceps tenotomy and open or arthroscopic biceps tenodesis. While tenotomy is a straightforward procedure with a quicker recovery time, it does have significant disadvantages including cosmetic deformity (Popeye's sign) and ongoing pain or cramping in the biceps. Currently, tenodesis is the preferred procedure due to the maintenance of the length tension relationship in the biceps, maintenance of elbow flexion and supination strength, and improved cosmetic appearance of the biceps. The biceps tenodesis procedure involves cutting the normal attachment of the LHBT at the glenoid fossa and reattaching it to the proximal humerus. There are a variety of fixation techniques used including soft tissue only and hardware fixation; interference screws, endobutton, and suture anchor techniques have all demonstrated similar load to failure, complication rates, and retear rates making implant selection largely a function of surgeon experience and comfort.
The use of knotless suture anchors for biceps tenodesis is one of the most recent developments in this surgical procedure. Knot-tying suture anchors may contribute to ongoing soft-tissue irritation at the site of the anchor and a knotless anchor may reduce this. The FOOTPRINT™ Ultra PK suture anchor (Smith and Nephew, United Kingdom) is a knotless suture anchor initially used in double-row rotator cuff repair but has expanded into the use in a variety of other surgical procedures. Proposed benefits of the system are the ability to use suture or suture tape, the ability to control tensioning and retensioning across the repair postanchor insertion which allows for more precise fixation in the final repair, and secure suture retention within the anchor eyelet due to the inner-locking plug leads to less suture slippage. In addition, the implant is also designed as a tap-in anchor with offset barbed geometry threads which add to its strong pullout strength. Finally, the implant's base material is polyetheretherketone which is an inert, nonabsorbable material that does not cause cytotoxicity and causes minimal inflammatory response and is becoming widely used in orthopedic implants. The purpose of this study was to evaluate the complication rates of biceps tenodesis procedures using the FOOTPRINT™ Ultra suture anchor.
| Materials and Methods|| |
This study was deemed institutional review board exempt by the health system clinical research committee. A retrospective observational study of a consecutive series of patients undergoing open or arthroscopic biceps tenodesis from October 2019 to December 2020 was conducted. All patients underwent biceps tenodesis using the FOOTPRINT™ Ultra PK suture anchor. Medical records were abstracted and patient demographics, surgical details, intraoperative and postoperative complications, and functional or patient-reported outcomes were recorded. Descriptive statistics were performed. The paired samples t-test was used to evaluate the change in functional and patient-reported outcomes from before surgical intervention to the last postoperative follow-up appointment. All statistical analyses were performed using the SPSS software version 27 (IBM, Armonk, NY, USA), and statistical significance was assessed at α = 0.05.
Patients receive instruction for a home exercise program including hand, wrist, and elbow range of motion (ROM) and shoulder pendulums to begin the day after surgery and formal physical therapy begins 10–14 days after surgery. Rehabilitation protocols advance from passive shoulder ROM starting at 2 weeks, active assist ROM starting between 4 and 6 weeks, and active ROM starting between 6 and 8 weeks postoperatively. All patients are discharged with a sling/shoulder immobilizer which is used at least for the first 6 weeks postoperatively. No lifting >5 pounds for at least the first 6 weeks following surgery.
| Results|| |
Twenty-nine patients were included in this study. Patients were 62.1% male, with a mean age of 55.5 ± 8.6 years (range 29–68 years) and a mean body mass index of 28.6 ± 5.4. The mean time to the last follow-up appointment was 8.5 ± 5.3 months. Arthroscopic tenodesis was performed in 20 (69.0%) cases with the other cases being open tenodesis [Table 1].
One (3.4%) patient status post open tenodesis experienced an infection in the first 30 days postoperatively that resulted in an emergency department visit and a return to the operating room for irrigation and debridement. Their recovery then progressed normally with no additional complications identified. One (3.4%) patient status post open tenodesis experienced a retear of their rotator cuff at 4 months postoperatively due to a bicycle accident and required additional surgery to repair this injury. The biceps tenodesis was noted to be intact at the time of the second surgery. One additional patient status postarthroscopic tenodesis was diagnosed with a retear of their rotator cuff at 11 months postoperatively by repeat magnetic resonance imaging and again the biceps tenodesis was noted to be intact. No intra- or postoperative device-related complications were noted in this study [Table 2].
The mean Numeric Rating Scale pain score decreased significantly when comparing the last preoperative score to the last postoperative score (5.9 vs. 1.9, P <.001). The last postoperative patient-reported outcome measurement information mental health (53.52 ± 8.96) and physical health (47.68 ± 11.25) was higher than the corresponding preoperative scores (MH: 52.28 ± 10.06; PH: 42.48 ± 5.46) though these results were not significant. There was no significant difference in Quick DASH scores preoperatively to postoperatively [Table 3].
|Table 3: Comparison of change in patient outcomes preoperative to postoperative by paired Samples t-test|
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| Discussion|| |
In this study, 29 patients underwent biceps tenodesis using the FOOTPRINT™ Ultra suture anchor. The population presented in this study is similar to the cohorts presented in previously published studies. The average age of patients in this study was 55.5 years and 62.1% were male. In a systematic review by Deng et al., the included studies had an average patient age ranging from 36.7 to 60.0 years and a range of 43%–94% male sex. While our mean age was on the high end compared to other published studies, we are within the expected range. Our overall complication rate is also comparable to other published studies. In a study by Schrøder et al., 2 of 39 patients undergoing biceps tenodesis underwent a reoperation within 1 year of the index procedure and neither reoperation was related to the tenodesis procedure. In our study, two patients underwent a reoperation within the first 6 months, one related to a surgical site infection and one related to a rotator cuff tear sustained in an unrelated traumatic incident during the postoperative recovery period; one patient was diagnosed with a recurrent rotator cuff repair at 11 months but has not had this repaired. Despite the small sample size presented in our study, the demographic characteristics are similar, increasing the likelihood that our cohort is representative to the larger patient population.
Various techniques have been described for biceps tenodesis fixation including soft-tissue tenodesis, suture button, suture anchor, and screw fixation. Numerous biomechanical studies have shown little difference in outcomes among the different fixation types in load to failure.,,, One study by Frank et al. did find that with torsional testing resulted in a spiral fracture of the humerus through the screw tunnel in 100% of specimens using interference screws and only 43% in the specimens in which suture anchors were used, indicating that suture anchor fixation may lead to a lower postoperative complication rate. One potential downside to suture anchor fixation is the presence of arthroscopic knots, which can lead to irritation of the surrounding tissues. The FOOTPRINT™ Ultra suture anchor is a knotless anchor; previous studies have shown that knotless suture anchors are a viable alternative in biceps tenodesis.,, Multiple studies have shown that open, subpectoral biceps tenodesis and arthroscopic suprapectoral biceps tenodesis have similar, excellent clinical results.,, One study by Gombera et al. found that open tenodesis procedures may increase the risk of complications due to a larger incision, but pain relief, function, and return to activity were similar when comparing open and arthroscopic procedures.
There were two patients who experienced postoperative complications requiring reoperation in our study cohort. One was a surgical site infection after open tenodesis that occurred 3 weeks postoperatively and required arthroscopic irrigation and debridement; the biceps tenodesis was intact at the time of the second surgery. In a study by Hughes et al., one patient of a cohort of 27 undergoing biceps tenodesis experienced an infection requiring washout. One additional patient experienced a retear of their rotator cuff repair that was performed in conjunction with the biceps tenodesis at 4 months postoperatively. This was due to a bicycle accident resulting in a recurrent rotator cuff tear that was surgically corrected; the biceps tenodesis was noted to be intact at the time of the second surgery. In general, the failure rate of biceps tenodesis is low. Green et al. published a study of arthroscopic and open tenodesis and found no failures in either group. A study by Gombera et al. also found no tenodesis failures in either the open or arthroscopic groups. Consistent with other published studies, biceps tenodesis with the FOOTPRINT™ Ultrasuture anchor is a safe and effective procedure with no failures noted in this study.
This study does have multiple limitations. First, its retrospective design increases the probability of selection bias and the potential that our findings are not applicable in other settings. Second, our study was designed primarily to examine the safety of a single device in the early postoperative period. Further study is required to evaluate whether biceps tenodesis surgery performed with the FOOTPRINT™ Ultra suture anchor produces improvement in function and quality of life that are similar or superior to other implant systems. We were also unable to verify patient functional status beyond the outcome scores collected in the study; work status and profession are not routinely collected for research purposes in this institution.
| Conclusion|| |
In this retrospective case series of 29 patients undergoing biceps tenodesis, there was a 6.9% complication rate observed in the first 6 months postoperatively. No device-related complications occurred. The FOOTPRINT™ Ultra suture anchor appears to be safe for use in patients undergoing arthroscopic or open biceps tenodesis.
This study received grant funding from Smith and Nephew.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]