Current and Expanded Indications for Cervical Disc Arthroplasty: Beyond the FDA IDE Studies.

The widespread success of cervical disc arthroplasty (CDA) has led to an interest in expanding indications beyond those outlined in the initial Food and Drug Administration investigational device exemption studies. Some of these off-label indications currently include 3-level and 4-level CDA, hybrid constructs with adjacent segment anterior cervical discectomy and fusion or corpectomy constructs, pre-existing kyphosis, revision of a failed anterior cervical discectomy and fusion to a CDA, CDA in the setting of significant degenerative disc disease and/or facet joint arthropathy, CDA for congenital cervical stenosis, and CDA in the presence of ossification of the posterior longitudinal ligament. This review article will summarize the current literature pertaining to the aforementioned indications.

Prognostic Factors Impacting Surgical Outcomes in Patients With Cervical Spondylotic Myelopathy.

The purpose of surgical decompression in patients who have CSM is to stop the progression of symptoms and hopefully improve function. It is critical to understand prognostic factors that affect the outcome. Factors intrinsic to the patient that can adversely affect outcomes include diabetes, older age, tobacco use, the presence of mental health disease, and obesity. MRI imaging findings of T2 hyperintensity and clinical duration and severity of symptoms is also associated with poorer outcomes. Patients should be counseled regarding the efficacy of decompressive procedures for CSM and given realistic expectations based on their unique biophysical profiles.

Interventional Spine and Pain Procedure Credentialing: Guidelines from the American Society of Pain & Neuroscience.

BACKGROUND: The discipline of interventional pain management has changed significantly over the past decade with an expected greater evolution in the next decade. Not only have the number of procedures increased, some of the procedures that were created for spine surgeons are becoming more facile in the hands of the interventional pain physician. Such change has outpaced academic institutions, societies, and boards. When a pain physician is in the credentialing process for novel procedure privileges, it can leave the healthcare system in a challenging situation with little to base their decision upon. METHODS: This paper was developed by a consensus working group from the American Society of Pain and Neuroscience from various disciplines. The goal was to develop processes and resources to aid in the credentialing process. RESULTS: These guidelines from the American Society of Pain and Neuroscience provide background information to help facilities create a process to appropriately credential physicians on novel procedures. They are not intended to serve as a standard or legal precedent. CONCLUSION: This paper serves as a guide for facilities to credential physicians on novel procedures.

Quantitative Assessment of the Anatomical Footprint of the C1 Pedicle Relative to the Lateral Mass: A Guide for C1 Lateral Mass Fixation.

STUDY DESIGN: Anatomic study. OBJECTIVES: To determine the relationship of the anatomical footprint of the C1 pedicle relative to the lateral mass (LM). METHODS: Anatomic measurements were made on fresh frozen human cadaveric C1 specimens: pedicle width/height, LM width/height (minimum/maximum), LM depth, distance between LM's medial aspect and pedicle's medial border, distance between LM's lateral aspect to pedicle's lateral border, distance between pedicle's inferior aspect and LM's inferior border, distance between arch's midline and pedicle's medial border. The percentage of LM medial to the pedicle and the distance from the center of the LM to the pedicle's medial wall were calculated. RESULTS: A total of 42 LM were analyzed. The C1 pedicle's lateral aspect was nearly confluent with the LM's lateral border. Average pedicle width was 9.0 ± 1.1 mm, and average pedicle height was 5.0 ± 1.1 mm. Average LM width and depth were 17.0 ± 1.6 and 17.2 ± 1.6 mm, respectively. There was 6.9 ± 1.5 mm of bone medial to the medial C1 pedicle, which constituted 41% ± 9% of the LM's width. The distance from C1 arch's midline to the medial pedicle was 13.5 ± 2.0 mm. The LM's center was 1.6 ± 1 mm lateral to the medial pedicle wall. There was on average 3.5 ± 0.6 mm of the LM inferior to the pedicle inferior border. CONCLUSIONS: The center of the lateral mass is 1.6 ± 1 mm lateral to the medial wall of the C1 pedicle and approximately 15 mm from the midline. There is 6.9 ± 1.5 mm of bone medial to the medial C1 pedicle. Thus, the medial aspect of C1 pedicle may be used as an anatomic reference for locating the center of the C1 LM for screw fixation.

Comparison of fatigue strength of C2 pedicle screws, C2 pars screws, and a hybrid construct in C1-C2 fixation.

STUDY DESIGN: A biomechanical study comparing the fatigue strength of different types of C2 fixation in a C1-C2 construct. OBJECTIVE: To determine the pullout strength of a C2 pedicle screw and C2 pars screw after cyclical testing and differentiate differences in stiffness pre- and post-cyclical loading of 3 different C1-C2 fixations. SUMMARY OF BACKGROUND DATA: Some surgeons use a short C2 pars screw in a C1-C2 construct, because it is less technically demanding and/or when the vertebral artery is high riding. Difference in construct stiffness between use of bilateral C2 pedicle screws, bilateral C2 pars screws, or a hybrid construct is unknown. METHODS: Biomechanical testing was performed on 15 specimens. A bicortical C1 lateral mass screw was used in combination with 1 of 3 methods of C2 fixation: (1) bilateral long C2 pedicle screws (LL), (2) bilateral 14-mm C2 pars screws (SS), and (3) unilateral long C2 pedicle screw with a contralateral 14-mm C2 pars screw (LS). Each construct was subject to 16,000 cycles to simulate the immediate postoperative period. Changes in motion in flexion-extension, lateral bending, and axial rotation were calculated. This was followed by pullout testing. RESULTS: The ability to limit range of motion significantly decreased after cyclical testing in flexion-extension, lateral bending, and axial rotation for all 3 groups. After loading, the LL and LS groups had less percentage of increase in motion in flexion-extension and lateral bending than the SS group. Overall, the average pullout strength of a pedicle screw was 92% stronger than a pars screw. CONCLUSION: C2 pedicle screws have twice the pullout strength of C2 pars screws after cyclical loading. In cases in which the anatomy limits placement of bilateral C2 pedicle screws, a construct using a unilateral C2 pedicle screw with a contralateral short pars screw is a viable option and compares favorably with a bilateral C2 pedicle screw construct. LEVEL OF EVIDENCE: N/A.

Correlation of posterior ligamentous complex injury and neurological injury to loss of vertebral body height, kyphosis, and canal compromise.

STUDY DESIGN: Retrospective, case-control study. OBJECTIVE: The purpose of this study was to determine if thoracolumbar vertebral body collapse, translation, or canal compromise (CC) is associated with injury to the posterior ligamentous complex (PLC) or neurological elements. SUMMARY OF BACKGROUND DATA: Radiographical parameters, including loss of vertebral body height (LOVBH), vertebral body translation, local kyphosis (LK), and CC, are often used as indicators of spinal instability. The hypothesis of this study was that LOVBH greater than 50%, LK greater than 20°, translation greater than 3.5 mm, or CC greater than 50% is associated with ligamentous and neurological injury. METHODS: Retrospective review of prospectively collected spinal cord injury database was performed. Inclusion criteria include consecutive patients with thoracolumbar burst fractures. Exclusion criteria include flexion-distraction injuries and pathological fractures. Computed tomographic scan measurements of the spine were performed by 2 experienced spine surgeons blinded to magnetic resonance imaging results. On magnetic resonance imaging, the supraspinous ligament, interspinous ligament, ligamentum flavum, facet joints, and disc were graded as intact, indeterminate, or disrupted. American Spinal Injury Association (ASIA) score and Frankel Scale score were recorded. Spearman correlation coefficients were calculated to evaluate relationships between vertebral body measurements, ligamentous injury, and neurological injury. RESULTS: Forty-six patients were included in the study. Ten patients had kyphosis greater than 20°, 1 patient had kyphosis greater than 30°, and 9 patients had LOVBH greater than 50%. There were 34 patients with vertebral body translation greater than 3.5 mm and 15 patients with CC greater than 50%. Sixteen patients had ligamentous injury. There was a significant correlation between subjacent segment translation greater than 3.5 mm and ligamentous injury (R = 0.323, P = 0.029) and ASIA motor score (R = -0.379, P = 0.009). There was no significant correlation between ligamentous injury or neurological injury and the following threshold parameters: LOVBH greater than 50%, vertebral body kyphosis greater than 20°, caudal or cephalad interspinous widening greater than 7 mm, CC greater than 50%, and sagittal transverse ratio less than 0.48. CONCLUSION: The results of this study indicate that LOVBH greater than 50% and LK greater than 20° are not predictive of PLC injury in thoracolumbar burst fractures. Translation greater than 3.5 mm was associated with PLC injury. The PLC and neural elements should be directly assessed with magnetic resonance imaging if there is clinical concern.

Impaired de novo choline synthesis explains why phosphatidylethanolamine N-methyltransferase-deficient mice are protected from diet-induced obesity.

Phosphatidylcholine (PC) is synthesized from choline via the CDP-choline pathway. Liver cells can also synthesize PC via the sequential methylation of phosphatidylethanolamine, catalyzed by phosphatidylethanolamine N-methyltransferase (PEMT). The current study investigates whether or not hepatic PC biosynthesis is linked to diet-induced obesity. Pemt(+/+) mice fed a high fat diet for 10 weeks increased in body mass by 60% and displayed insulin resistance, whereas Pemt(-/-) mice did not. Compared with Pemt(+/+) mice, Pemt(-/-) mice had increased energy expenditure and maintained normal peripheral insulin sensitivity; however, they developed hepatomegaly and steatosis. In contrast, mice with impaired biosynthesis of PC via the CDP-choline pathway in liver became obese when fed a high fat diet. We, therefore, hypothesized that insufficient choline, rather than decreased hepatic phosphatidylcholine, was responsible for the lack of weight gain in Pemt(-/-) mice despite the presence of 1.3 g of choline/kg high fat diet. Supplementation with an additional 2.7 g of choline (but not betaine)/kg of diet normalized energy metabolism, weight gain, and insulin resistance in high fat diet-fed Pemt(-/-) mice. Furthermore, Pemt(+/+) mice that were fed a choline-deficient diet had increased oxygen consumption, had improved glucose tolerance, and gained less weight. Thus, de novo synthesis of choline via PEMT has a previously unappreciated role in regulating whole body energy metabolism.

Lack of phosphatidylethanolamine N-methyltransferase alters plasma VLDL phospholipids and attenuates atherosclerosis in mice.

OBJECTIVE: Impaired hepatic phosphatidylcholine (PC) synthesis lowers plasma lipids. We, therefore, tested the hypothesis that lack of phosphatidylethanolamine N-methyltransferase (PEMT), a hepatic enzyme catalyzing PC biosynthesis, attenuates the development of atherosclerosis. METHODS AND RESULTS: Mice deficient in both PEMT and low-density lipoprotein receptors (Pemt(-/-)/Ldlr(-/-) mice) were fed a high-fat/high-cholesterol diet for 16 weeks. Atherosclerotic lesion area was approximately 80% lower (P<0.01) in Pemt(-/-)/Ldlr(-/-) mice than in Pemt(+/+)/Ldlr(-/-) mice, consistent with the atheroprotective plasma lipoprotein profile (ie, significant reduction in very low-density lipoprotein [VLDL]/intermediate-density lipoprotein/low-density lipoprotein-associated phospholipids [approximately 45%], triacylglycerols [approximately 65%], cholesterol [approximately 58%], and cholesteryl esters [approximately 68%]). Plasma apoB was decreased by 40% to 60%, whereas high-density lipoprotein levels were not altered. In addition, PEMT deficiency reduced plasma homocysteine by 34% to 52% in Pemt(-/-)/Ldlr(-/-) mice. The molar ratio of PC/phosphatidylethanolamine in nascent VLDLs produced by Pemt(-/-)/Ldlr(-/-) mice was lower than in VLDLs in Pemt(+/+)/Ldlr(-/-) mice. Furthermore, deletion of PEMT modestly reduced hepatic VLDL secretion in Ldlr(-/-) mice and altered the rate of VLDL clearance from plasma. CONCLUSIONS: This is the first report showing that inhibition of hepatic phospholipid biosynthesis attenuates atherosclerosis.

An anatomical study of the mid-lateral pars relative to the pedicle footprint in the lower lumbar spine.

STUDY DESIGN: An anatomic study that describes the relationship of the pedicle center to the mid-lateral pars (MLP) in the lower lumbar spine as a guide to pedicle screw placement. OBJECTIVE: Describe morphometric data of the lower lumbar pedicles, the unique coronal pedicle footprints of L4 and L5, and their impact on the relationship of the pedicle center to the MLP. SUMMARY OF BACKGROUND DATA: Traditional medial-lateral starting points for lumbar pedicle screws use the facet as an anatomic reference for all lumbar levels. The facet is often a difficult landmark to use secondary to degenerative changes and the desire to minimize damage to the facet capsule in the most cephalad level. These techniques can also result in pedicle violation particularly in the lower lumbar spine. Use of the nonarthritic MLP is proposed in this study as an alternative anatomic reference point for the pedicle center. METHODS: Seventy-two pedicles (L3-S1) from embalmed cadaveric spines were used. Linear and angular dimensions of the pedicle were measured, including the degree of coronal pedicle tilt of L4 and L5. The center of the pedicle relative to the MLP and relative to the midline of the base of the transverse process was measured. The axial superior facet angle and angle of pedicle screw insertion were also measured. RESULTS: The minimum pedicle width was 10.9 and 12.4 mm and the coronal pedicle tilt was 36 degrees and 55 degrees for L4 and L5, respectively. A classification of 2 types of L5 pedicles relevant to pedicle center location was developed. In the medial-lateral direction, the pedicle center is 2.9 mm lateral to the MLP at L3 and L4. At L5, it is 1.5 and 4.5 mm lateral to the MLP for a type I and type II pedicle, respectively. In the superior-inferior direction, the pedicle center is 1 mm superior to the midline of the transverse process base for all lower lumbar levels. Significant differences between a type I and II L5 pedicle were a larger pedicle width and distance of the pedicle center to the MLP for a type II pedicle. The difference between the axial pedicle screw insertion angle and anatomic superior facet angles was 8 degrees from L4-S1. CONCLUSION: The MLP is a reliable anatomic reference point for the center of the pedicle in the lower lumbarspine. Consideration needs to be taken when inserting pedicle screws at L4 and L5 because of the degree of their coronal tilts and unique pedicle footprints. It is important to distinguish a type I from type II L5 pedicle as a type II pedicle is wider, has a more lateral pedicle center relative to the MLP, and has the potential for lateral screw placement while still remaining within the pedicle.

An anatomic and radiographic study of lumbar facets relevant to percutaneous transfacet fixation.

STUDY DESIGN: An anatomic study of lumbar facet anatomy for transfacet fixation. OBJECTIVE: Describe the ideal starting point and trajectory for percutaneous transfacet fixation. SUMMARY OF BACKGROUND DATA: Percutaneous transfacet fixation is gaining popularity for posterior stabilization after anterior lumbar interbody fusion. Despite biomechanical and clinical studies, there are no anatomic guidelines for safe placement of percuatenous transfacet screws. METHODS: Eighty L3-S1 facet joints from embalmed cadaveric spines were analyzed. Linear and angular measurements of the facets were recorded. Under direct visualization, the segments were pinned with an ipsilateral transfacet technique. The degrees of angulation in the sagittal and axial plane were recorded. The distances of the starting point relative to landmarks of the superior body were measured. Under fluoroscopy, radiographic parameters for ideal visualization of the pin and pin ending points were determined. RESULTS: Inferior and superior facet heights ranged from 15.7 to 17.5 mm at all levels. The percentage of inferior facet extending below the L3 and L4 end plates was 84% and 86% respectively and decreased at L5 to 72%. The percentage of superior facet extending above the end plate ranged from 36% to 44% at all levels. The transverse facet angle progressively increased from L3 to S1. The L2-L3 segments could not be instrumented from the ipsilateral side due to the vertical facet orientation. For L3-S1 segments, the starting point in the coronal plane is based on the superior body of the instrumented segment and should be in line with the medial border of the pedicle in the medial-lateral direction and in line with the inferior end plate in the cranial-caudal direction. The screw should be laterally angulated approximately 15 degrees in the axial plane approximately 30 degrees caudally in the sagittal plane. The screw should end in the inferolateral quadrant of the pedicle on the AP radiograph and at the pedicle-vertebral body junction on the lateral radiograph. 35 degrees of axial rotation is the optimal fluoroscopic view for confirming screw placement. CONCLUSION: Ipsilateral transfacet fixation can be successfully performed in the L3-S1 segments by using the inferior end plate and medial pedicle wall of the superiorly instrumented level as anatomic landmarks in conjunction with axial and sagittal angles of insertion.

Basicervical versus intertrochanteric fractures: an analysis of radiographic and functional outcomes.

This retrospective study compared the long-term stability and functional outcomes of basicervical versus intertrochanteric fractures, and evaluated the use of an additional derotational screw in the treatment of basicervical fractures. Sixty-six patients (28 with basicervical fractures and 38 treated for stable and unstable intertrochanteric fractures) were identified. All intertrochanteric fractures were treated with a sliding hip screw. Basicervical fractures were treated with a sliding hip screw with or without a derotational screw. Radiographically measured fracture collapse and tip-apex distance were measured at least 6 weeks after surgery; SF-36 score and Functional Recovery Score data was collected at least 1 year after surgery. The proportion of fractures with > 10% collapse was significantly greater in the basicervical group than the subset of stable intertrochanteric fractures (P = .009), but not than the subset of unstable intertrochanteric fractures. The mean SF-36 bodily pain section domain was greater (less pain) in the basicervical group than the unstable intertrochanteric group (P = .02). No other significant differences in SF-36 scores were noted between the basicervical and either intertrochanteric group. Basicervical fractures collapse more than stable intertrochanteric fractures, suggesting that they may have greater biomechanical instability. This instability, however, does not translate into clinically significant decreases in functional outcome. Using a derotational screw with a sliding hip screw does not affect fracture stability or clinical outcome.

Vitallium radial head prosthesis for acute and chronic elbow fractures and fracture-dislocations involving the radial head.

This retrospective study aims to evaluate the radiographic, functional, and patient-derived outcomes of 16 patients who each received a Vitallium radial head prosthesis for unreconstructable acute fractures of the radial head, as well as previously treated fractures of the radial head associated with residual instability, pain, and stiffness. Follow-up averaged 33 months. A trend toward greater disability and poorer motion was noted in the delayed treatment group compared with the acute replacement group. Overall, the results were excellent in 5 patients, good in 10, and poor in 1, as determined by the Mayo Elbow Performance Score. All elbows were stable at follow-up, and no patient reported wrist pain. Four required further operative treatment of their elbow injuries. Metallic radial head arthroplasty yields satisfactory results in acute unreconstructable radial head fractures or as a salvage procedure for previously treated radial head fractures.

A device for zone-II flexor tendon repair. Surgical technique.

BACKGROUND: The stainless-steel Teno Fix tendon-repair device has improved biomechanical characteristics compared with those of suture repair, and it was well tolerated in a canine model. The purpose of this study was to compare the Teno Fix with suture repair in a clinical setting. METHODS: Sixty-seven patients with isolated zone-II flexor tendon injury were randomized to be treated with a Teno Fix or a four-stranded cruciate suture repair. There were eighty-five injured digits: thirty-four were treated with the Teno Fix, and fifty-one served as controls. A modified leinert rehabilitation technique was employed, with active flexion starting at four weeks postoperatively. Patients were followed for six months by blinded observers who determined the range of motion, Disabilities of the Arm, Shoulder and Hand (DASH) score, pinch and grip strength, and pain score on a verbal scale and assessed swelling and neurologic recovery. Adverse outcomes, including device migration and rupture, were monitored at frequent intervals. RESULTS: Nine of the fifty-one suture repairs ruptured, whereas none of the Teno Fix repairs ruptured (p < 0.01). Five of the nine ruptures were caused by resistive motion against medical advice. There were no differences between the two groups in terms of range of motion, DASH score, pinch and grip strength, pain, swelling, or neurologic recovery. The Teno Fix group had slightly slower resolution of pain and swelling compared with the control group. Of the patients who were available for follow-up at six months, sixteen of the twenty-four treated with a Teno Fix repair and nineteen of the twenty-seven treated with a control repair had a good or excellent result. One Teno Fix device migrated and extruded secondary to a wound infection. Of all eighty-five digits that were operated on, four were thought to have tendons of inadequate size to accommodate the device and nine were deemed to have inadequate exposure to allow placement of the anchors. CONCLUSIONS: The Teno Fix is safe and effective for flexor tendon repair if the tendon size and exposure are sufficient. Tendon repairs with the Teno Fix have lower rupture rates and similar functional outcomes when compared with conventional repair, particularly in patients who are non-compliant with the rehabilitation protocol.

Device for zone-II flexor tendon repair. A multicenter, randomized, blinded, clinical trial.

BACKGROUND: The stainless-steel Teno Fix tendon-repair device has improved biomechanical characteristics compared with those of suture repair, and it was well tolerated in a canine model. The purpose of this study was to compare the Teno Fix with suture repair in a clinical setting. METHODS: Sixty-seven patients with isolated zone-II flexor tendon injury were randomized to be treated with a Teno Fix or a four-stranded cruciate suture repair. There were eighty-five injured digits: thirty-four were treated with the Teno Fix, and fifty-one served as controls. A modified Kleinert rehabilitation technique was employed, with active flexion starting at four weeks postoperatively. Patients were followed for six months by blinded observers who determined the range of motion, Disabilities of the Arm, Shoulder and Hand (DASH) score, pinch and grip strength, and pain score on a verbal scale and assessed swelling and neurologic recovery. Adverse outcomes, including device migration and rupture, were monitored at frequent intervals. RESULTS: Nine of the fifty-one suture repairs ruptured, whereas none of the Teno Fix repairs ruptured (p < 0.01). Five of the nine ruptures were caused by resistive motion against medical advice. There were no differences between the two groups in terms of range of motion, DASH score, pinch and grip strength, pain, swelling, or neurologic recovery. The Teno Fix group had slightly slower resolution of pain and swelling compared with the control group. Of the patients who were available for follow-up at six months, sixteen of the twenty-four treated with a Teno Fix repair and nineteen of the twenty-seven treated with a control repair had a good or excellent result. One Teno Fix device migrated and extruded secondary to a wound infection. Of all eighty-five digits that were operated on, four were thought to have tendons of inadequate size to accommodate the device and nine were deemed to have inadequate exposure to allow placement of the anchors. CONCLUSIONS: The Teno Fix is safe and effective for flexor tendon repair if the tendon size and exposure are sufficient. Tendon repairs with the Teno Fix have lower rupture rates and similar functional outcomes when compared with conventional repair, particularly in patients who are noncompliant with the rehabilitation protocol.

A 15- to 25- year follow-up study of primary Charnley low-friction arthroplasty: a single surgeon series.

Long term outcome studies are essential to determine the effectiveness and durability of a procedure. We report our 15 to 25 year clinical and radiographic follow-up with the Charnley low-friction hip arthroplasty. Four hundred and forty-seven primary Charnley hip arthroplasties were performed by a single surgeon. Ninety-eight of the 447 hips from 75 patients were available for follow up at average of 18.9 years (range 15.3 to 25.4 years). Seventy-two hips (73.5%) survived clinically. Of these 72, seventy-one stems (98.6%) and 60 sockets (83.3%) survived radiographically. Kaplan-Meier survival analysis on all 447 hips using revision as an endpoint revealed 66.2% +/- 5.7% survival at 20 years. Twenty-six hips were revised. The main reason for revision was failure of the socket. Complications included dislocation (3 of 98 hips), heterotopic ossification (7 of 98 hips), trochanteric wire breakage (6 of 98 hips), and trochanteric non-union (1 of 98 hips). Charnley low-friction hip arthroplasty is an effectiveand durable procedure. Key words: hip, arthroplasty, charnley, follow-up.

The biomechanical analysis of a tendon fixation device for flexor tendon repair.

PURPOSE: Stainless steel suture is high in tensile strength but is not widely used in flexor tendon repair because of difficulty with handling and knot tying. The purpose of this study was to examine the biomechanical characteristics of the single-strand multifilament stainless steel Teno Fix device (Ortheon Medical, Winter Park, FL) designed for zone II flexor digitorum profundus (FDP) tendon repair. METHODS: Sixty cadaveric flexor tendons were transected and randomized to receive a Teno Fix or 4-stranded (3-0 or 4-0 braided polyester) suture repair; all repairs were tested with and without a 5-0 monofilament polypropylene circumferential epitendinous suture. By using a material testing system all tendons were tested to failure in tension using a linear model with a loading rate of 1 mm/s. Stiffness, force, and energy at both 2-mm gap and peak force were calculated from the resulting force-displacement curves. RESULTS: The 2-mm gapping force was significantly greater for the Teno Fix and the 3-0 repairs than for the 4-0 repairs. The energy absorbed up to 2-mm gap was significantly greater for the Teno Fix, however, than for all suture repairs both with and without a circumferential suture. There was no statistically significant difference in peak force or energy absorbed at peak force between the Teno Fix and suture repairs; the average gap at peak force for all repairs was 5.2 mm. The addition of a circumferential suture increased the 2-mm gapping and peak forces of the Teno Fix repair to 54.5 N and 66.7 N, respectively. CONCLUSIONS: Increased strength and energy absorbed at 2-mm gap and ease of installation makes the Teno Fix a promising repair method.