Predictors of Medical Malpractice Outcomes After Spine Surgery: A Comprehensive Analysis From 2010 to 2019.

STUDY DESIGN: Retrospective review of spine surgery malpractice cases. OBJECTIVES: The aim was to compare medical malpractice outcomes among different types of spine surgery and identify predictors of litigation outcomes. SUMMARY OF BACKGROUND DATA: Spine surgery is highly litigious in the United States with data suggesting favorable outcomes for defendant surgeons. However, factor specific data and explanations for plaintiff verdicts are lacking. METHODS: Westlaw legal database was queried for spine surgery malpractice outcomes from 2010 to 2019. Clinical data, reasons for litigation, and legal outcomes were tabulated. Statistical analysis was performed to identify factors associated with litigation outcomes. RESULTS: A total of 257 cases were identified for inclusion. There were 98 noninstrumented and 148 instrumented cases; 110 single-level and 99 multilevel; 83 decompressions, 95 decompression and fusions, and 47 fusion only. In all, 182 (71%) resulted in a defendant verdict, 44 (17%) plaintiff verdict, and 31 (12%) settlement. Plaintiff verdicts resulted in payouts of $2.03 million, while settlements resulted in $1.11 million (P=0.34). Common reasons for litigation were intraoperative error, hardware complication, and improper postoperative management. Cases were more likely to result for the plaintiff if postoperative cauda equina syndrome (55% vs. 26%, P<0.01), a surgical site infection (46% vs. 27%, P=0.03), or other catastrophic injury (40% vs. 26%, P=0.03) occurred. Higher monetary awards were associated with multi versus single-level (median: $2.61 vs. $0.92 million, P=0.01), improper postoperative management cited (median: $2.29 vs. $1.12 million, P=0.04), and permanent neurological deficits ($2.29 vs. $0.78 million, P<0.01). Plaintiff payouts were more likely if defendant specialty was neurosurgery versus orthopedic surgery (33% vs. 18%, P=0.01). CONCLUSIONS: Spine surgery is a litigious field with multiple factors associated with outcomes. Efforts to reduce intraoperative errors and complications may improve patient care and decrease the risk of litigation.

Correction to: Intervertebral disc penetration by antibiotics used prophylactically in spinal surgery: implications for the current standards and treatment of disc infections.

Unfortunately, the complete conflict of interest statement was missed out in the original publication. The same is given below.

Intervertebral disc penetration by antibiotics used prophylactically in spinal surgery: implications for the current standards and treatment of disc infections.

PURPOSE: The presence of Propionibacterium acnes in a substantial component of resected disc specimens obtained from patients undergoing discectomy or microdiscectomy has led to the suggestion that this prominent human skin and oral commensal may exacerbate the pathology of degenerative disc disease. This hypothesis, therefore, raises the exciting possibility that antibiotics could play an important role in treating this debilitating condition. To date, however, little information about antibiotic penetration into the intervertebral disc is available. METHODS: Intervertebral disc tissue obtained from 54 microdiscectomy patients given prophylactic cefazolin (n = 25), clindamycin (n = 17) or vancomycin (n = 12) was assayed by high-performance liquid chromatography, with cefaclor as an internal standard, to determine the concentration of antibiotic penetrating into the disc tissue. RESULTS: Intervertebral disc tissues from patients receiving the positively charged antibiotic clindamycin contained a significantly greater percentage of the antibacterial dose than the tissue from patients receiving negatively charged cefazolin (P < 0.0001) and vancomycin, which has a slight positive charge (P < 0.0001). CONCLUSION: Positively charged antibiotics appear more appropriate for future studies investigating potential options for the treatment of low-virulence disc infections. These slides can be retrieved under Electronic Supplementary Material.

Use of the subcutaneous lumbar spine (SLS) index as a predictor for surgical complications in lumbar spine surgery.

BACKGROUND CONTEXT: Lumbar spine surgeries require adequate exposure to visualize key structures and limited exposure can make surgery more technically difficult, thus increasing the potential for complications. Body mass index and body mass distribution have been shown to be associated with worse surgical outcomes. PURPOSE: This study aims to further previous investigations in elucidating the predictive nature of body mass distribution with peri- and postoperative complications in lumbar surgery. STUDY DESIGN/SETTING: This is a retrospective study conducted at a single institution. PATIENT SAMPLE: Two hundred eighty-five patients who underwent lumbar laminectomy, laminotomy, or posterior lumbar interbody fusion or transforaminal lumbar interbody fusion procedures between 2013 and 2016. OUTCOME MEASURES: Magnetic resonance imaging (MRI) results and electronic medical records were reviewed for measurements and relevant complications. METHODS: Previously known risk factors were identified and MRI measurements of subcutaneous adipose depth (SAD) relative to spinous process height (SPH) were measured at the surgical site to generate the subcutaneous lumbar spine (SLS) index. This measurement was then analyzed in association with recorded surgical complications. RESULTS: The SLS index was found to be a significant risk factor for total complications (0.292, p=.041), perioperative complications (0.202, p=.015), and need for revision surgery (0.285, p<.001). The SAD alone proved to be negatively associated with perioperative complications (-0.075, p=.034) and need for revision surgery (-0.104, p=.001), with no predictive association seen for total or postoperative complications. Linear regression revealed an SLS index of 3.43 as a threshold value associated with a higher risk of total complications, 5.8 for perioperative complications, and 3.81 for the need for revision surgeries. CONCLUSION: Body mass distribution of the surgical site as indicated by SAD to SPH (SLS index) is significantly associated with increasing risk of postoperative and perioperative complications as well as increased likelihood for necessary revision surgery. This relationship was shown to be a more accurate indication of perioperative risk than previous standards of body mass index and SAD alone, and may allow spine surgeons to assess surgical risk when considering lumbar spine surgery using simple calculations from standard preoperative MRI results.

Propionibacterium acnes biofilm is present in intervertebral discs of patients undergoing microdiscectomy.

BACKGROUND: In previous studies, Propionibacterium acnes was cultured from intervertebral disc tissue of ~25% of patients undergoing microdiscectomy, suggesting a possible link between chronic bacterial infection and disc degeneration. However, given the prominence of P. acnes as a skin commensal, such analyses often struggled to exclude the alternate possibility that these organisms represent perioperative microbiologic contamination. This investigation seeks to validate P. acnes prevalence in resected disc cultures, while providing microscopic evidence of P. acnes biofilm in the intervertebral discs. METHODS: Specimens from 368 patients undergoing microdiscectomy for disc herniation were divided into several fragments, one being homogenized, subjected to quantitative anaerobic culture, and assessed for bacterial growth, and a second fragment frozen for additional analyses. Colonies were identified by MALDI-TOF mass spectrometry and P. acnes phylotyping was conducted by multiplex PCR. For a sub-set of specimens, bacteria localization within the disc was assessed by microscopy using confocal laser scanning and FISH. RESULTS: Bacteria were cultured from 162 discs (44%), including 119 cases (32.3%) with P. acnes. In 89 cases, P. acnes was cultured exclusively; in 30 cases, it was isolated in combination with other bacteria (primarily coagulase-negative Staphylococcus spp.) Among positive specimens, the median P. acnes bacterial burden was 350 CFU/g (12 - ~20,000 CFU/g). Thirty-eight P. acnes isolates were subjected to molecular sub-typing, identifying 4 of 6 defined phylogroups: IA1, IB, IC, and II. Eight culture-positive specimens were evaluated by fluorescence microscopy and revealed P. acnes in situ. Notably, these bacteria demonstrated a biofilm distribution within the disc matrix. P. acnes bacteria were more prevalent in males than females (39% vs. 23%, p = 0.0013). CONCLUSIONS: This study confirms that P. acnes is prevalent in herniated disc tissue. Moreover, it provides the first visual evidence of P. acnes biofilms within such specimens, consistent with infection rather than microbiologic contamination.

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis.

Interspinous process decompression is a minimally invasive implantation procedure employing a stand-alone interspinous spacer that functions as an extension blocker to prevent compression of neural elements without direct surgical removal of tissue adjacent to the nerves. The Superion® spacer is the only FDA approved stand-alone device available in the US. It is also the only spacer approved by the CMS to be implanted in an ambulatory surgery center. We computed the within-group effect sizes from the Superion IDE trial and compared them to results extrapolated from two randomized trials of decompressive laminectomy. For the ODI, effect sizes were all very large (>1.0) for Superion and laminectomy at 2, 3, and 4 years. For ZCQ, the 2-year Superion symptom severity (1.26) and physical function (1.29) domains were very large; laminectomy effect sizes were very large (1.07) for symptom severity and large for physical function (0.80). Current projections indicate a marked increase in the number of patients with spinal stenosis. Consequently, there remains a keen interest in minimally invasive treatment options that delay or obviate the need for invasive surgical procedures, such as decompressive laminectomy or fusion. Stand-alone interspinous spacers may fill a currently unmet treatment gap in the continuum of care and help to reduce the burden of this chronic degenerative condition on the health care system.

The effects of a semiconstrained integrated artificial disc on zygapophyseal joint pressure and displacement.

STUDY DESIGN: Measurement of zygapophyseal joint pressure and displacement was performed after placement of a semiconstrained integrated artificial disc (SIAD) in a cadaver model. OBJECTIVE: To understand the likelihood of accelerated zygapophyseal joints degeneration as a result of the implant. SUMMARY OF BACKGROUND DATA: A SIAD has been developed to treat lumbar spondylosis secondary to segmental disc degeneration and spinal stenosis. The SIAD replaces the stenotic segment's disc. Previous studies have demonstrated that nonconstrained artificial disc (NAD) replacements fail to achieve their optimal long-term outcomes likely because of significantly increased zygapophyseal joint pressure and displacement at the implanted level. Moreover, clinical studies have reported an increased incidence of zygapophyseal joint degeneration after lumbar disc replacement. METHODS: Eight cadaver lumbar specimens (L2-L5) were loaded in flexion, neutral, extension, left bend, and right rotation. Zygapophyseal joint pressure and displacement were measured during each of the 5 positions at each of the 3 levels with the ratio of deformation calculated under the different loads. An artificial disc was placed at the L3-L4 level, and the measurements were repeated. RESULTS: After L3-L4 segment implantation, the pressure in the zygapophyseal joint at operative segment was not significantly changed by SIAD and NAD implantation in axial compression and flexion, compared with physiological disc. Notable differences in zygapophyseal joint pressure between the SIAD and NAD were identified at the operative level in extension, left bend, and right rotation. The adjacent-level effect of NAD was significantly greater than that of SIAD. The ratio of deformation difference between the 2 discs was increased by load experienced in extension, flexion, left bend, and right rotation. CONCLUSION: The SIAD provided a superior biomechanical milieu for zygapophyseal joints at the implanted and adjacent levels compared with NAD, which may avoid the acceleration of postoperative zygapophyseal joint degeneration. LEVEL OF EVIDENCE: 1.

One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis.

BACKGROUND: Sacroiliac joint (SI) pain is an often-overlooked cause of lower-back pain, due in part to a lack of specific findings on radiographs and a symptom profile similar to other back-related disorders. A minimally invasive surgical (MIS) approach to SI joint fusion using a series of triangular, titanium plasma spray-coated implants has shown favorable outcomes in patients with SI joint pain refractory to conservative care. The aim of this study was to provide a multicenter experience of MIS SI joint fusion using a patient-level analysis. PATIENTS AND METHODS: We report a patient-level analysis from 144 patients with a mean of 16 months postoperative follow-up. Demographic information, perioperative measures, complications, and clinical outcomes using a visual analog scale for pain were collected prospectively. Random-effects regression models were used to account for intersite variability. RESULTS: The mean age was 58 years, 71% of patients were female, and 62% had a history of lumbar spinal fusion. Mean (95% confidence interval [CI]) operative time was 73 minutes (25.4-118), blood loss was minimal, and hospital stay was 0.8 days (0.1-1.5). At follow-up, mean (95% CI) visual analog scale pain scores improved by 6.1 points (5.7-6.6). Substantial clinical benefit, defined as a decrease in pain by >2.5 points or a score of 3.5 or less, was achieved in 91.9% of patients (95% CI 83.9%-96.1%), and 96% (95% CI 86.3%-98.8%) of patients indicated they would have the same surgery again. CONCLUSION: When conservative measures fail to relieve symptoms resulting from degeneration or disruption of the SI joint, MIS SI joint fusion using a series of triangular, porous, titanium plasma spray-coated implants is a safe and effective treatment option.

Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes.

BACKGROUND: Sacroiliac (SI) joint pain is an under diagnosed source of low back pain due in part to lack of visible pathology on radiographs and symptoms mimicking other back-related disorders. Open SI joint fusion has been performed since the 1920s. This technique has fallen out of favor with the introduction of minimally invasive options. To date there has been no direct comparison between open and MIS SI joint fusion. METHODS: We conducted a multi-center, retrospective comparative cohort study of patients who underwent SI joint fusion using either an open surgical (OS) technique using a combination of screws and cages or a minimally invasive surgical (MIS) technique with a series of titanium plasma spray (TPS) coated triangular implants. Operative measures including surgical operating time, length of hospitalization and estimated blood loss (EBL) were collected along with demographics and medical history, surgical complications, and 12- and 24-month pain scores. Improvements in pain were compared after matching for age and gender and controlling for a history of lumbar spine fusion using repeated measures analysis of variance. RESULTS: Data were available for 263 patients treated by 7 surgeons; 149 patients treated with OS and 114 treated with MIS SI joint fusion. Compared to OS patients, MIS patients were on average 10 years older (mean age 57 vs. 46) and 69% of all patients were female. MIS operative measures of EBL, operating time and length of hospitalization were significantly lower than open surgery (p < 0.001). Pain relief, measured as change from baseline to 12 months in VAS pain rating, was 3.5 points lower in the MIS vs. OS group (-6.2 vs. -2.7 points, p < 0.001). When matched for age, gender and a history of prior lumbar spinal fusion, postoperative pain scores were on average 3.0 points (95% CI 2.1 - 4.0) lower in MIS vs. OS (rANOVA p < 0.001). CONCLUSIONS: In this multi-center comparative study, patients who underwent either OS or MIS SI joint fusion showed postoperative improvements in pain score. Compared to OS patients, patients who underwent MIS SI joint fusion had significantly greater pain relief and more favorable perioperative surgical measures.

A comprehensive subaxial cervical spine injury severity assessment model using numeric scores and its predictive value for surgical intervention.

Multiple factors contribute to the determination for surgical intervention in the setting of cervical spinal injury, yet to date no unified classification system exists that predicts this need. The goals of this study were twofold: to create a comprehensive subaxial cervical spine injury severity numeric scoring model, and to determine the predictive value of this model for the probability of surgical intervention. In a retrospective cohort study of 333 patients, neural impairment, patho-morphology, and available spinal canal sagittal diameter post-injury were selected as injury severity determinants. A common numeric scoring trend was created; smaller values indicated less favorable clinical conditions. Neural impairment was graded from 2-10, patho-morphology scoring ranged from 2-15, and post-injury available canal sagittal diameter (SD) was measured in millimeters at the narrowest point of injury. Logistic regression analysis was performed using the numeric scores to predict the probability for surgical intervention. Complete neurologic deficit was found in 39 patients, partial deficits in 108, root injuries in 19, and 167 were neurologically intact. The pre-injury mean canal SD was 14.6 mm; the post-injury measurement mean was 12.3 mm. The mean patho-morphology score for all patients was 10.9 and the mean neurologic function score was 7.6. There was a statistically significant difference in mean scores for neural impairment, canal SD, and patho-morphology for surgical compared to nonsurgical patients. At the lowest clinical score for each determinant, the probability for surgery was 0.949 for neural impairment, 0.989 for post-injury available canal SD, and 0.971 for patho-morphology. The unit odds ratio for each determinant was 1.73, 1.61, and 1.45, for neural impairment, patho-morphology, and canal SD scores, respectively. The subaxial cervical spine injury severity determinants of neural impairment, patho-morphology, and post-injury available canal SD have well defined probability for surgical intervention when scored separately. Our data showed that each determinant alone could act as a primary predictor for surgical intervention.

Surgical outcomes of elderly patients with cervical spondylotic myelopathy.

BACKGROUND: Cervical spondylotic myelopathy is a potentially serious neurologic disorder that commonly presents with gait difficulty and hand dysfunction. Because the development of CSM is in large part related to advanced spondylosis and degenerative disk disease, elderly patients appear to be at an increased risk to develop this condition. The surgical outcomes of this patient population have been understudied; the authors seek to report their clinical results in a series of patients with CSM older than 75 years who underwent surgical treatment. METHODS: This report is composed of a cohort of 36 elderly patients (older than 75 years) and 34 younger patients (younger than 65 years) who underwent decompressive surgery for CSM at one institution between 2001 and 2005. The patients' functional status was evaluated preoperatively and postoperatively using the mJOA disability scale. RESULTS: The mean follow-up time in the elderly group was 24 months, with a range from 12 to 48 months. There was a statistically significant improvement between mean preoperative (11.3) and postoperative (14.4) mJOA scores (P< .0001). The younger group had a higher neurologic recovery rate (71%) than the elderly group (59%); however, this was not statistically significant (P= .29). The postoperative complication rate in the elderly population (38%) was higher than in the younger group (6%; P= .002). CONCLUSION: Elderly patients with CSM are likely to obtain neurologic improvement after decompressive surgery. Their postoperative complication rate is higher than that of younger patients, yet most complications appear to be self limiting and do not adversely affect neurologic outcome.

A novel application of high-dose (50kGy) gamma irradiation for demineralized bone matrix: effects on fusion rate in a rat spinal fusion model.

BACKGROUND CONTEXT: The safety of allograft material has come under scrutiny because of recent reports of allograft-associated bacterial and viral infections in tissue recipients. Gamma irradiation, although being one of the most effective ways of terminal sterilization, has been shown to affect the biomechanical properties of allograft bone. It may also have detrimental effects on the osteoinductivity of allograft material such as demineralized bone matrix (DBM) by the denaturation of proteins because of heat generated by irradiation. Sterilization of DBM material is an important variable in processing graft materials. This is considered to be one of the factors leading to different fusion rates observed with different commercially available DBM products, as the sterilization procedure itself may affect the osteoinductivity of the material. Currently, there is no ideal sterilization technique that limits the detrimental effect on osteoinductivity and fusion rates. PURPOSE: To evaluate the effects of a range of hydrogen peroxide exposures with or without the controlled high-dose gamma irradiation after processing with radioprotectant solutions (Clearant radiation sterilization procedure) on the fusion rates of human DBM. STUDY DESIGN: A prospective in vivo animal study. METHODS: Eighty mature athymic nude female rats were used for this study, which formed 10 equal groups. Human DBM exposed to hydrogen peroxide for different time periods (0, 1, 6, and 24 hours) was divided into two major subgroups. One group was further treated with controlled high-dose radiation using radioprotectants (radiation treated), whereas the other group was frozen immediately without specific treatment (non-radiation treated). Both radiation-treated and non-radiation-treated DBM material from each group of hydrogen peroxide exposure times were implanted between L4 and L5 transverse processes of the rats forming eight test groups including eight animals in each. The remaining 16 rats were divided into two additional groups to form negative (only decortication, n=8) and positive (bone morphogenetic protein [BMP]-2, n=8) control groups. The rats were evaluated for fusion by radiographs (2, 4, and 8 weeks), manual palpation (8 weeks), and histological analysis after sacrificing. Comparison of fusion rate among all groups was made using these three evaluation methods. RESULTS: Increasing the time period of hydrogen peroxide (0, 1, 6, or 24 hours) exposure for preparation of DBM from bone allograft did not affect the fusion rates significantly (p<.05), although there was a trend toward decreasing fusion rates with longer exposure times. When the hydrogen peroxide washed DBM preparations were also radiation treated, the resulting fusion rates were again not significantly different (p<.05). Agreement among fusion detection methods was found to be high. CONCLUSIONS: Hydrogen peroxide processing was not detrimental to fusion rates. The additional terminal sterilization technique with special gamma irradiation protocols (Clearant process) also did not decrease the fusion rates but could provide an additional margin of safety.

A thoracic and lumbar spine injury severity classification based on neurologic function grade, spinal canal deformity, and spinal biomechanical stability.

BACKGROUND CONTEXT: Current well regarded thoracic and lumbar spine injury classifications use mechanistic and anatomical categories, which do not directly rely on quantifiable management parameters. Their clinical usefulness is not optimal. PURPOSE: Formulate an injury severity based classification. STUDY DESIGN/SETTING: This retrospective investigation studied patients who suffered thoracic and lumbar spine injuries, and examined the following three quantifiable parameters: 1) neurologic function grade; 2) spinal canal deformity; 3) biomechanical stability. These parameters are the primary clinical indications for management decisions. PATIENT SAMPLE: One hundred twenty-six consecutive patients with spinal trauma admitted to a level 1 tertiary trauma center from January 1997 to November 2005 were enrolled in this study. OUTCOME MEASURES: Spine injury severity was independently scored on three parameters: 1) neurologic function impairment grade according to the modified Frankel grading method and the American Spinal Injury Association (ASIA) function scale; 2) spinal canal deformity from translation and intrusion, measured as percent canal cross-sectional area compromise; 3) failure of five possible biomechanical functions in Denis's three anatomic columns, and a sixth group of unstable deformities. All three columns contribute to tensile function. Only the anterior and middle columns provide compression load-bearing function. A combination of three or more column biomechanical function failure or an unstable deformity renders the injury unstable. METHODS: Five fellowship-trained spine surgeons from one institution took part in the study. Hospital medical records, including admission history and physical examination, discharge summary, and operative report (if surgery was performed), were examined for neurologic deficit. Plain radiographs, computed tomographic scans and magnetic resonance imaging were assessed for canal compromise and biomechanical function status. RESULTS: Injuries were located from T3 to L5, 58% of which were at the thoracolumbar junction (T11-L2). Neurologic impairment occurred in 45% (57/126) of patients, with 19 complete paraplegias (Frankel grade A). The average spinal canal cross-sectional area compromise was 56.1% in neurologically impaired and 14.2% for patients who where neurologically intact. The number of tensile element failure patients in neurologically impaired versus intact are as follow: tri-columns 22/4; two columns 16/8; one column 11/17; all columns intact 8/40. Load-bearing element failed in 55/57 neurologically impaired and 63/69 intact patients. Sixty-seven patients had spinal reconstructive surgery. Their average instability profile score was 4.4 out of 6, and canal compromise score was 3.3 out of 5. CONCLUSIONS: A clinically useful thoracic and lumbar spine injury classification should be based on parameters that are the primary indications for management decisions. The same parameters should be injury severity quantifiable as to guide treatment. In this study we introduced spinal canal deformity and column biomechanical functions as quantifiable parameters in thoracic and lumbar injury severity classification. Validation of this method is beyond the scope of this preliminary study.

The effect of uniform heating on the biomechanical properties of the intervertebral disc in a porcine model.

BACKGROUND CONTEXT: The use of minimally invasive lumbar intradiscal heating techniques, including intradiscal electro-thermal therapy (IDET), endoscopic radio-frequency annuloplasty, nucleoplasty and laser discectomy, for chronic lumbar discogenic pain and contained disc herniation has recently gained popularity. The purported therapeutic mechanisms of these interventions include subtotal nuclectomy, annular nociceptor ablation, and stabilization of the annular fibers. Basic science data elucidating the biomechanical and histomorphologic alterations of heat treatments on disc remain sparse. PURPOSE: The purpose of this study is to examine the effects of uniform heating on biomechanical properties and histomorphology of intervertebral disc tissues using a porcine model. STUDY DESIGN/SETTING: In a laboratory setting, porcine functional spinal units consisting of vertebra-nucleus pulposus-vertebra core and porcine hamstring tendons were harvested. Studies were performed on these tissue samples by uniformly heating the specimens in a constant temperature water bath. Ten porcine lumbar disc core and twenty-five porcine hamstring tendons were utilized as the subjects for this study. The effects of uniform heat treatments on disc core and hamstring tendon were measured for shrinkage, stiffness, and load to failure strength. Histomorphological study was also carried on the same specimen. METHODS: The porcine vertebra-nucleus pulposus-vertebra segments were cored to a uniform 1-cm diameter. The hamstring tendons were cut to uniform 1.2-inch lengths. The tendon specimens were divided into groups of five each and heated in constant temperature water baths of 60 degrees C, 65 degrees C, 70 degrees C, or 75 degrees C for 10 min. Unheated specimens served as controls. The disc core specimens were divided in two group of five each, and tested at room temperature or after immersion in a 70 degrees C bath. The shrinkage was monitored during immersion in the water bath. Biomechanical testing to failure was carried out using mechanical loading on an MTS servohydraulic testing machine operating under stroke control. Strength and stiffness of the tissue was determined. Histomorphology was studied by staining the specimen with hematoxylin and eosin (H&E), and examined under 200 times magnification. Non-heated controls were used for comparisons. RESULTS: The porcine hamstring tendons had no measurable shrinkage in specimens heated up to 65 degrees C. At temperatures above 65 degrees C, the shrinkage was concluded within 2 min of immersion and 70 degrees C appeared to be the optimal temperature, as temperatures higher than this did not demonstrate incremental effects. The disc core samples were heated to 70 degrees C (optimum temperature), and there appeared to be gross contraction of the disc core circumference to visual inspection, but no measurable lengthwise shrinkage could be appreciated. Histologically, the specimens demonstrated progressive loss of individual collagen fiber outline as the temperature increased. In the tendons, at 75 degrees C all of the fibers appear to be fused together, and the voids between individual collagen fibers were no longer present. Biomechanical testing revealed that the tendons undergo a substantial reduction in stiffness after heating. The mean tendon stiffness for the unheated specimens was 19,356 psi, while the corresponding value for the heated tendons was 1023 psi. These were significantly different using the paired t-test at p=0.0043. For the disc core samples, there was no significant difference in either stiffness (p=0.182) or failure strength (p=0.998) after heating. All failures occurred in mid-substance of the specimen. CONCLUSIONS: The application of uniform heating to nucleus pulposus disc core caused visible contraction of its circumference but not lengthwise shrinkage. The same heating shrinks the hamstring tendon and reduces its stiffness. Ultimate failure strength of the disc core specimen remains unchanged. The failure data was not obtainable for the tendon due to premature slippage from the fixation apparatus before failure. The results of this study fail to support a biomechanical justification for the application of uniform heat treatment to the whole intervertebral disc. Heating annulus fibrosus and nucleus pulposus separately to specific temperatures may have potential clinical benefits.