Progressive osteolysis of the radius after distal biceps tendon repair with the bioabsorbable screw

Progressive osteolysis of the radius after distal biceps tendon repair with the bioabsorbable screw

J Shoulder Elbow Surg (2011) 20, 819-826 www.elsevier.com/locate/ymse Progressive osteolysis of the radius after distal biceps tendon repair with th...

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J Shoulder Elbow Surg (2011) 20, 819-826

www.elsevier.com/locate/ymse

Progressive osteolysis of the radius after distal biceps tendon repair with the bioabsorbable screw Anna Potapov, MD, Yves G. Laflamme, MD, FRCSC, Sylvain Gagnon, MD, FRCSC, Fanny Canet, MScA, Dominique M. Rouleau, MD, MSc, FRCSC* Departement de chirurgie, Centre de recherche, H^opital du Sacre-Coeur de Montreal, Universite de Montreal, Montreal, Quebec, Canada Background: Several complications have been reported with the use of the PLLA (poly-L-Lactide) bioabsorbable screw in orthopedic surgery. The hypothesis was that the use of a bioabsorbable screw in distal biceps tenodesis results in significant osteolysis of the radial bone. The correlation between osteolysis and functional and clinical outcomes was also studied. Methods: All consecutive patients who underwent anatomic repair of the distal biceps tendon with a bioabsorbable screw were included. From the x-ray taken immediately after the surgery, the ratio between the volume of the bone tunnel and the volume of the radius bone section was measured. This relation was calculated at different follow-up periods to obtain the percentage of tunnel enlargement over time. Complications, as well as functional and clinical outcomes, were also assessed. Mayo Elbow Performance Score (MEPS), the quick-Disability Arm Shoulder Hand (DASH), and the Short-Form 12 (SF-12) were used. Results: Nineteen consecutive patients were available for follow-up. The average initial relative volume occupied by the screw tunnel was 49% of the bone section and increased to 61% at the last follow-up at an average of 22 months (range, 3-62 months). Eight of the 19 patients presented postoperative complications. There was only 1 case of complete bone filling of the tunnel, which was observed at a 5-year and 2-months follow-up. There was no significant correlation between the volume of bone resorption and functional and clinical outcomes. Discussion: No correlation was found between the volume of bone tunnel and the functional outcome. However, the results indicate that the use of a bioabsorbable screw in distal biceps tendon repair results in significant bone osteolysis. Level of evidence: Level IV, Case Series, Treatment Study. Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Osteolysis; biceps tendon; bioabsorbable screw; complications

Distal biceps tendon rupture comprises approximately 3% of all ruptures of the biceps tendon.21 Operative repair of the biceps tendon to the radial tuberosity has been IRB approval: 2010-03-24. *Reprint requests: Dominique M. Rouleau, MD, MSc, FRCSC, Centre de recherche, H^ opital du Sacre-Coeur de Montreal, local K-3035, 5400, boul. Gouin ouest, Montreal, Quebec, Canada H4J 2C5. E-mail address: [email protected] (D.M. Rouleau).

demonstrated to improve flexion and supination strength compared with conservative treatment by 30% and 40%, respectively.5,42,44 Anatomical repair can be performed using either a 1- or 2-incision technique. The main complications include nerve lesions, heterotrophic ossification, and re-rupture of the tendon.45 Presently, no consensus has been reached regarding the preferred approach. Trans-osseous suture repair described by Morrey et al was the standard

1058-2746/$ - see front matter Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. doi:10.1016/j.jse.2011.02.021

820 operative procedure to fix the distal biceps tendon.24,44,53 Afterwards, newer fixation techniques of the distal biceps tendon have been introduced and include suture anchors,24,35,36 bioabsorbable screws,23,25,32,52 and button.4 The loads to failure of these fixation techniques have only been investigated in a few biomechanical studies and the results are controversial.10,28,39 The bioabsorbable fixation screw is an interference screw that has been routinely used for knee ligament reconstruction and proximal biceps tenodesis.7,12,49,50 For repair of the distal biceps tendon, this technique has the advantage of being done through a smaller incision, allowing an anatomic fixation of the tendon and being biocompatible and biodegradable.38 However, there are potential complications that have been reported with its use in other areas of orthopedic surgery, namely foreign-body reaction, osteolysis, cyst formation, screw fracture, and diminished mechanical properties.56 Osteolysis is a potential problem in the larger bones of the body, but its potential consequences are certainly also significant in a smaller bone such as the radius. We therefore asked: (1) if the use of the bioabsorbable screw in distal biceps tendon repair would result in significant radial osteolysis and what type of clinical complications would occur; and (2) assessed whether there was any relation between tunnel screw osteolysis, functional, and clinical outcomes and the occurrence of complications.

Materials and methods This retrospective study consisted of all consecutive patients treated with distal biceps tendon repair using the poly-L-lactide (PLLA) bioabsorbable interference screw (Arthrex, Naples, Florida, USA) from 2005 to 2009. Patients were identified based on a chart review and a query of senior authors (SG) prospectively collected surgical data. Inclusion criteria for this study were patients aged older than 18 years who have undergone a distal biceps tendon repair using the bioabsorbable screw. Patients with ipsilateral upper limb disease other than the distal biceps tendon tear were excluded.

Patient evaluation This study received ethical approval from the review boards of all involved institutions. All participants gave their written consent and were invited for a functional evaluation. At the last follow-up, functional evaluation was performed using the Mayo Elbow Performance Score (MEPS), the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH), and the ShortForm 12 (SF-12). The MEPS is a widely applied measure of function of the elbow.43 It is a clinician-completed score that includes four categories, namely pain, motion, stability, and the ability to perform five functional tasks. The Quick-DASH score is a validated patient-oriented rating scale that analyzes 11 factors involved in activities of daily living, followed by optional questions.2 The SF-12 is a valid measure of health status in patients with a variety of upper extremity disorders.40 Passive and active

A. Potapov et al. elbow ROM was measured using a goniometer and arm and forearm circumferences were measured.

Surgical technique All surgeries were completed by senior authors (SG) through either a 1- or 2-incision technique as described previously.17,38 After debridement of the biceps tendon to healthy tissue, a nonabsorbable suture was passed in a whipstitch fashion in the distal 10e15 mm of the tendon so that its ends emerged at the distal tendon end. A guide pin (Arthrex) was drilled through the radial tuberosity until it passed through the dorsal cortex. The guide wire was then over reamed through both cortices with an 8 mm acorn reamer (Arthrex). The sutures were then passed through the driver with the screw mounted onto it. Screw insertion was done as per Biotenodesis system guidelines. Once the screw was inserted, the suture tails were tied against the radius.

Radiological evaluation Plain radiographs, consisting of an AP and lateral view of the elbow, were used to estimate the relative volume of bone loss from the screw insertion in relation to the volume of the proximal radius. The following measurements were done on the postoperative x-ray at 3 months and at the last follow-up. The mathematical formula for cylindrical volume was used,  2 d p h; 2 to assess the screw volume tunnel and the volume of the radius bone section. The formula was used as follows: 1) to determine the screw tunnel volume, the diameter of the screw tunnel in the radius (d) and the diameter of the radius (D) were used in the formula, as D represents the height (h) of the screw tunnel; 2) to determine the volume of the radius bone section, D was used as the diameter and d as the height of the cylinder, as shown on Figure 1, A. The relative volume of bone loss was calculated by dividing the volume of the bone tunnel by the volume of the radius bone section. After cancellation of common variables in the numerator and denominator, the relative volume formula was simplified to d/D (Fig. 1, B). Additionally, the radial bone tunnel diameter (d) was measured at 3 equally separated points along the cylinder tunnel and the average value was used. The percentage of tunnel enlargement was obtained by relating the volumetric ratio at each evaluation time point. The initial theoretical relative volume of bone loss due to surgical drilling was calculated by using the peri-operative drill size. At the last follow-up, a computed tomography (CT scan) was performed to assess screw continuity, the degree of tunnel filling, and to calculate the relative volume of bone loss from a cut where the largest portion of the cylinder was seen. Finally, the radiological records were also reviewed for evidence of heterotopic ossification and radioulnar synostosis.

Postoperative rehabilitation The elbow was immobilized in 90 of flexion and neutral rotation for 7 to 14 days, followed by active and passive range of motion (ROM). A protection splint was worn in between exercises for the

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Figure 1 (A) Bone tunnel in a radial bone section. D ¼ diameter of the radius bone section and height of the radial bone tunnel; d ¼ diameter of the radial bone tunnel and height of the radius bone section. (B) Relative volume formula. first 6 weeks. Patients were first seen from 1 to 2 weeks postoperatively with radiographs of the elbow. Afterwards, they were followed up at 2 weeks, 3 months, and again if complications occurred. The last follow-up visit was requested for the purposes of the study during which subjects underwent a functional and radiological evaluation.

Statistical analysis Descriptive statistics were used to describe patient demographics, functional and clinical outcomes, and complications. Paired Student t tests were used to compare the relative volumes between time intervals and for comparison of morphometric measurements of the injured versus uninjured side. Pearson’s correlation coefficient was used to characterize the relationship of osteolysis to functional outcomes, range of motion, and complications. A correlation between the relative volume of the bone tunnel measured on the x-ray and the CT scan was also evaluated using Pearson’s correlation. A P value of <.05 was considered significant.

Another patient with a chronic tear operated at 4 years was the only patient in the series with a partial tear. One case was a revision surgery for anchor failure at 2 weeks. A 7- x 23-mm screw was used in 16 patients and 8- x 23-mm and 8- x 12-mm screws in the other 2 cases. The screws were implanted through either a 1- (n ¼ 8) or 2-incison (n ¼ 11) technique. The first 11 cases were done through a 2-incision approach and the last 8 cases through a 1-incision approach. This is due to surgeons’ evolution of practice.

Osteolysis

After conducting a database and chart review, 22 patients were identified. Twenty patients met the inclusion criteria. Nineteen of them (95%) were available for assessment at a minimum of 3 months follow-up. The mean follow-up was 22 months (range, 3-62 months). All patients were male. The mean age at the time of surgery was 46 years (range, 31-61). All patients had a mechanism suggestive of excessive eccentric extensile loading of the flexed arm. Nine patients injured their dominant side.

There was a significant increase in the relative tunnel volume between 2 weeks and 3 months (50% vs 63%, P < .05), and between 2 weeks and the final average follow-up of 22 months (50% vs 61%, P < .05, n ¼ 18). There was no difference between the initial relative volume of the drill hole at the time of operation and the relative volume at 2 weeks (49% vs 50%). A CT scan was performed at an average follow-up of 18 months in 13 patients for the purposes of the study. The relative volume of the bone tunnel measured by an independent evaluator on the CT-scan at the last follow-up was 60%, and showed a good correlation with the x-ray measurement (R2 ¼ .766, P <.01). Ten out of 13 patients had a persistent screw on the CT scan at their last follow-up, and a typical example is shown in Figure 2. The average followup was 4.3 years for the only 3 patients whose screws were not seen on the scans. Only 1 patient had the screw replaced completely by bone identified on the CT scan at 5 years and 2 months. Following our ethics committee’s recommendations, patients can refuse to undergo a CT-scan for research purposes to diminish radiation exposure, and such was the choice for 6 of the subjects.

Surgery description

Complications

The mean delay to surgery was 12.5 days (range, 1-1338). Three patients had chronic tears, and only 1 of them required an autologous hamstring graft due to a retracted tendon 3 months following a complete distal biceps tear.

Overall, we noted 8 complications in 19 patients (Table I). One patient required numerous reoperations for a foreign-body reaction to the screw with massive osteolysis (Fig. 3, A). At 6 weeks postoperatively, the patient

Results Cohort

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A. Potapov et al.

Discussion

Figure 2 An example of screw persistence in the radius on an axial computed tomography scan (Fig. 3, A) and a coronal MRI image (Fig. 3, B) at a 2-year follow-up. Table I

Postoperative complications Number of patients

Complex regional pain syndrome (type 2) Foreign-body reaction Temporary posterior interosseus nerve palsy Heterotopic ossification 2 grade 1 Screw fracture Chronic biceps spasm

1 1 2 2 1 1

presented with a painful discharging sinus, with local swelling and tenderness noted at the wound site. The differential diagnosis included a foreign-body reaction or infection without fever. Massive osteolysis at the screw site was seen on radiographs. The patient underwent debridement and screw removal. All culture samples were negative including for propionibacterium acnes. Histological examinations of the tissue samples collected intraoperatively confirmed the diagnosis of a foreign-body inflammatory reaction. The patient’s inflammatory symptoms resolved after removal of the screw and bony regrowth was seen 9 months postoperative (Fig. 3, B). Another patient presented with screw breakage at 8 weeks without any history of trauma (Fig. 4). This patient was treated nonoperatively by rest and pain subsided at 6 months postoperative.

Functional and clinical outcomes We did not find any correlation between the amount of osteolysis and the functional outcome scores, pain level, ROM, and arm or forearm circumferences. Furthermore, there was no difference between the operated and normal sides in terms of morphometric measurements (Table II). The MEPS score was 91.4  12.6 on a maximum of 100 for a normal elbow. Furthermore, the average Quick-DASH score was 15.9  19.1 and 0 is the best score.

Various implants are being used for distal biceps tendon repair, including transosseous sutures,24,44,53 suture anchors,24,35,36 button,4 and the bioabsorbable interference screw which has gained popularity in recent years.23,25,32,52 The bioabsorbable screw has been widely used in knee surgery and, more recently, in shoulder, foot and ankle, spine, and orthopaedic trauma surgery.1 The reported advantages of the bioabsorbable screw in distal biceps tendon repair include its facility of fixing the tendon through a 1-incision technique, its biocompatibility, and its gradual degradation with eventual replacement by bone.15,16 However, complications with these implants have been reported, including foreign-body reactions, osteolysis, cyst formation, screw fracture, and diminished mechanical properties.8,9,15,51,56 To the best of our knowledge, no such complications have been reported with the use of the bioabsorbable screw in distal biceps tendon repair. We have shown that there was a significant increase in the relative tunnel volume between the immediate postoperative period and final average follow-up of 22 months. Furthermore, the only case of complete bony replacement of the screw happened at the longest follow-up of 5 years and 2 months. This is the first study measuring radial bone osteolysis in distal biceps tendon repair. The use of a relation of the tunnel volume to the volume of the radial bone section, rather than use the absolute value of the tunnel volume,26,37 was preferred for several reasons. First, it accounts for the magnification error. Second, it compensates for the variability in tunnel and radial bone sizes of the patients in this study. There was a very good correlation between the measurements done on the x-ray and the CTscan in all of the 13 patients that supports the validity of our methodology. A single case report32 and 3 case series25,32,52 describing the clinical use of the bioabsorbable interference screw in repair of distal biceps tendon rupture have been published. These studies focus on functional outcomes without evaluating radiological complications related to the use of a bioabsorbable screw. A variety of bioabsorbable screws with different material properties are available. Compared to the polyglycolic implants, the next-generation, PLLA polymer implants were intended to minimize the occurrence of lysis, loosening, and foreign-body reaction.15,16 Nevertheless, several reports describe osteolysis with the use of PLLA implants. In ACL reconstruction with the PLLA screw, osteolysis has been reported in 16-66% of patients after 2 years.18,22,37 Additionally, femoral tunnel widening by 53-77% was shown after 2 years in patients with ACL repair.37 Buelow et al reported tunnel enlargement of up to 75% after a few weeks and up to 100% of the initial volume at 6 months.18 The etiology of bone tunnel enlargement is poorly understood. Foreign-body immune response,27 bone necrosis secondary to drilling,

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Figure 3 (A) Six-week postoperative radiograph of a patient with a foreign-body reaction showing massive osteolysis. (B) Nine-month postoperative radiograph showing bony regrowth of the same patient who underwent debridement and screw removal.

Figure 4

Table II

A coronal MRI image performed 8 weeks postoperatively for a patient who presented with screw breakage.

Morphometric measurements (n ¼ 19) Injured side Mean  SD

Flexion ( ) Extension ( ) Pronation ( ) Supination ( ) Arm diameter (cm) F-arm diameter (cm)

128 10 67 69 31 26

     

15 24 17 18 4 2

Normal side Mean  SD 132 2 72 75 31 26

     

5 4 7 10 4 2

SD, standard deviation. )Student paired t test with significance level higher than 0.05 in all cases.

and tendon-tunnel motion27,30,47 have been implicated as the causes of osteolysis. In knee surgery, the extent of tunnel enlargement has not been shown to affect clinical results.3,18,20 Similarly, we have not found any correlation between osteolysis and clinical and functional outcome scores, or the occurrence of complications. However, due to the smaller size of the radial bone, we believe that potentially serious complications, such as fractures through the bone tunnel, should not be overlooked. In ACL repair, only

a few cases of tibial and femoral tunnel fractures have been reported.34,54,55 Although the mechanical effect of bone tunnels secondary to bioabsorbable screws has not been specifically established, reduction in bone strength following implant removal or hole drilling has been welldocumented in orthopedic literature.19,31 Only 1 of our patients had a complete replacement of the screw by bone at the last follow-up. This patient had the longest follow-up of 5 years. It is known that PLLA implants have a slower degradation rate compared to polyglycolide implants; however, there exists a great variability in the absorption rate of the PLLA screw. Its duration of biodegradation has been reported to range from 3 years, and remnants of the screw have been found to persist after as long as 7 years.6,22 Hence, the duration of complete degradation of the PLLA screw is unpredictable and possibly depends on manufacturing and handling of each individual screw.11 The functional outcome results obtained in the present series are comparable to the results of other studies of distal biceps tenodesis. McKee et al reported 53 cases with anchor repair and an average DASH of 8.2 vs 15.9 in our cohort for the Quick-DASH.41 Silva et al reported 29 patients with bio-tenodesis repair and an average DASH of

824 6.52 Peeters et al described 26 cases using endobutton (ÓSmith and Nephew, London, UK) repair with an average MEPS score of 94 vs 91.4 in their cohort.46 Fenton et al included 14 patients with a mean MEPS of 97 using a biotenodesis screw.25 At 6 months follow-up, Eardley et al reported 14 cases of biotenodesis repair with an average DASH of 7 and mean MEPS of 96.23 Similar to the results of our study, all studies obtained excellent rehabilitation of ROM and showed no significant difference in ROM of the injured side compared to the controlateral side.23,25,41,46,52 There was no correlation between the amount of osteolysis and functional outcome in our study. This could be explained by local fibrosis or bicortical screw fixation which provided sufficient fixation. We found 2 cases of severe bioabsorbable screw related complications. The first case involved a foreign-body reaction to the screw. The tissue response triggered by bioabsorbable implants has been described as an inflammatory, aseptic, foreign-body response.13,14 These tissue responses range from being mild reactions that resolve uneventfully to severe, inflammatory foreign-body reactions that require surgery.15 Although PLLA implants are expected to minimize foreign-body reaction due to their longest in vivo degradation time,6,48 there have been several reports documenting the presence of foreign-body reaction with PLLA screws.9,16,57 Our patient presented with a discharging sinus which raised suspicion for infection. Discharging sinuses are more common with the use of polyglycolide implants compared to PLLA implants.15 Even though infection was suspected, the negative cultures and early postoperative disappearance of inflammatory symptoms supported the diagnosis of a foreignbody reaction. The second bioabsorbable screw related complication case involved screw breakage, which occurred at 8 weeks without any history of trauma. There are only a few cases reported of PLLA screw breakage,29 where most of these cases happened 1 year following surgery. Hall et al reported a case of tibial PLLA screw breakage at 4 months following minor trauma, and concluded that it was unlikely because of screw degradation but probably secondary to screw malposition.29 The choice of a longer screw than what is reported in the literature (23 vs 12 mm) in most of our patients could have led to hardware prominence, impingement on the ulna, and toggling.23,25,52 This could potentially trigger osteolysis or screw breakage. The frequency of the other complications that we reported, namely complex regional pain syndrome, temporary posterior interosseus nerve palsy, and minimal heterotopic ossification, were similar to the rates found in other studies.23,25,41,46,52 The small number of patients is 1 of the limitations of this study. We also lacked a control group treated with other fixation methods. However, the other available fixation options have been studied more extensively in distal biceps tendon repair compared to the bioabsorbable screw.33 Another limitation is that the main authors, who were not

A. Potapov et al. blinded from the hypothesis of the study, measured the tunnel volumes which might lead to bias. This potential source of bias was addressed by keeping the authors blinded to the date of the images from which the measurements were taken, and by asking an independent evaluator to perform the measurements on the CT-scan, which produced a good correlation (R ¼ .76) with the calculations from the x-ray.

Conclusion This study showed that the use of a bioabsorbable screw for distal biceps tendon fixation results in significant osteolysis of the radial bone at short term follow-up. We also found 2 cases of severe biotenodesis-screw related complications. Although there was no significant correlation between the amount of osteolysis and functional and clinical outcomes, these results call into question the use of the bioabsorbable screw in distal biceps. Future studies on distal biceps tenodesis using different fixation methods should report the effect of the implant on the radial bone. Other fixation options, including shorter biotenodesis PEEK (Poly-Ether Ether Ketone) screws, anchors, or buttons, are possible alternatives.

Acknowledgments This work was supported by the Service d’Orthopedie de l’H^opital du Sacre-Cœur de Montreal. The authors wish to thank Dr. Eric Beaumont for many helpful comments and suggestions.

Disclaimer No author, their immediate family, and any research foundation with which they are affiliated have received any financial payments or other benefits from any commercial entity related to the subject of this article.

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