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Biomedical subjects

B B Hall

Publications and source records attributed to B B Hall.

9 recordsLinked to original sources

The safety and efficacy of the Isola Spinal Implant System for the surgical treatment of degenerative disc disease. A prospective study.

STUDY DESIGN: This is a prospective study designed in consultation with and approved by the Food and Drug Administration with the purpose of determining the safety and efficacy of the Isola Spinal Implant System for the surgical treatment of patients with degenerative disc disease. OBJECTIVES: To report the results of the degenerative disc disease group from the Isola Investigational Device Exemption study, which was done to determine whether the Isola Spinal Implant System is a safe and effective treatment. SUMMARY OF BACKGROUND DATA: The safety and efficacy of transpedicular instrumentation as an adjunct in achieving lumbar spine fusion are still debated. METHODS: Hospital Investigational Review Board approval of the study protocol was obtained at the 10 participating centers. One hundred twenty patients (49 men and 71 women; average age, 54 years [range, 25-83 years]) were enrolled. Clinical and radiographic follow-up evaluation was done using protocols established prospectively. RESULTS: Of the 120 patients, 12 (10%) had device-related problems. There were two operative and four device related complications after surgery. Six other patients had their implants removed either for local pain (two) or for looseness or breakage (four). Of 118 patients eligible for follow-up evaluation at 24 months, 107 (91%) were available for study. Fusion was achieved in 97 (91%) patients. Average combined function and pain scores improved by 2.6 points (P < 0.0001). Clinical success, as measured by combining function and pain scores, was achieved in 65% of the patients by the most stringent criteria and 73% by less stringent criteria. Clinical success was significantly higher in patients who had not had previous surgery than in those who had, 77% versus 57% (P = 0.04). CONCLUSIONS: The present study suggests that the Isola Spinal Implant System can be safely used, is an effective adjunct in the achievement of fusion, and yields an acceptable number of successful clinical outcomes, especially when considering the preponderance of previously operated patients included in this group.

Bone Nails↗

Adjacent-segment degeneration after lumbar fusion with instrumentation: a retrospective study.

Adjacent-segment degeneration is a known consequence of spinal fusion. Factors associated with this, and its effect on results, have not been well identified. This study sought to determine factors associated with adjacent-segment degeneration and the effect this degeneration has on results after lumbar fusion and instrumentation. Forty-nine patients were retrospectively reviewed after lumbar fusion with instrumentation and analyzed for adjacent-segment degeneration. Adjacent-segment degeneration occurred in 17 (35%) patients and was associated with increasing patient age, the use of interbody fusion, and a worsening of clinical results with time. In older patients with stenosis, it was associated with previous surgery. This should be considered when choosing operative techniques in treating lumbar pathologic conditions, especially in older patients.

Age Factors↗

Anaerobic septic arthritis and osteomyelitis.

Anaerobic septic arthritis and osteomyelitis are more common than previously believed. Recent experience suggests that because of the high morbidity associated with these conditions, a very aggressive surgical and medical treatment program is indicated.

Aged↗

Primary realignment of posterior urethral injuries.

The records of 34 patients with posterior urethral disruptions secondary to blunt pelvic trauma who were treated with primary realignment were reviewed. Among the 29 evaluable patients there was a 38 per cent incidence of stricture (11 of 29), a 3 per cent incidence of incontinence (1 of 29) and a 15 per cent incidence of impotence (4 of 27). Primary realignment has a low morbidity and an acceptable rate of incontinence, impotence and stricture formation, and is recommended in the treatment of posterior urethral injuries.

Adolescent↗

Anaphylactic reactions following the intradiscal injection of chymopapain under local anesthesia.

During the twelve-year period from January 1, 1970, through December 31, 1981, 4,282 patients with the diagnosis of herniated nucleus pulposus were treated by intradiscal injection of chymopapain under local anesthesia. Fifteen (0.35 per cent) of these patients sustained an anaphylactic reaction as defined by us. Twelve patients had subjective early warning signs before their blood pressure decreased, including a total-body burning or tingling sensation (five patients), a general feeling of ill health (four patients), and diffuse pruritus (three patients). Profound hypotension without subjective warning symptoms was the first indication of anaphylaxis in three patients. In all patients, hypotension requiring vigorous treatment was the life-threatening clinical manifestation of anaphylaxis, but respiratory distress severe enough to require endotracheal intubation did not occur. There were no deaths or known sequelae. Ten of the fifteen patients were women. Review of the medical histories of the fifteen patients and follow-up telephone interviews did not identify any other pre-disposing factor for the anaphylaxis. Twelve of the fifteen patients obtained complete relief of the symptoms of disc herniation. The advantage of the use of local rather than general anesthesia for chymopapain injection is that the patient remains responsive and can give an early warning of the subjective symptoms of anaphylaxis if they appear. This potential for early diagnosis allows early and aggressive treatment with intravenous fluids, epinephrine, steroids, and antihistamines, which can be effective in preventing death or permanent sequelae. In our experience, general anesthesia and routine endotracheal intubation are not necessary for intradiscal injection of chymopapain.

Adult↗

Fluid spaces in normal and osteomyelitic canine bone.

When cortical bone is afflicted by an infectious process, significant alterations in the physiology and anatomy occur at the cellular level. Included in these alterations are modulations of the various fluid spaces of cortical bone. Volume of distribution studies with 14C-labeled sucrose and 99Tc-labeled red blood cells in an animal model of acute, subacute, and chronic osteomyelitis of the tibia were performed to quantitate the various fluid spaces in cortical bone. Additionally, the studies were performed in cortical bone from the radius and tibiae (following sham operations) to allow comparison with normal and control values. The total exchangeable water, vascular, and interstitial fluid spaces were increased in all three types of osteomyelitic bone. With one-way analysis of variance and Duncan's multiple range test, the alterations observed in each type of osteomyelitic bone (acute, subacute, or chronic) were statistically different from those observed in normal bone (p = 0.001) and controls (p less than or equal to 0.01). The differences of the mean values observed among the three types of osteomyelitic bone were not statistically significant (p greater than 0.05). These pathophysiologic alterations in osteomyelitic bone must be considered when one studies the ability of various antimicrobials to reach bactericidal concentrations in the interstitial fluid space, the primary site of drug-microorganism interaction.

Acute Disease↗

Spinal fusions to the sacrum in adults with scoliosis.

Forty-five skeletally mature patients averaging 44.3 years of age had spinal fusions which extended to the sacrum for pain and/or progression of their scoliosis. The primary diagnosis was idiopathic scoliosis in 35 patients, congenital scoliosis in two patients, and paralytic scoliosis in eight patients. A single curve pattern was present in 41 patients and the remainder had double primary curves. Thirty-eight patients had single stage procedures and 35 of these were done posteriorly. There was an evolution in the type of posterior instrumentation used over the 12 years. Thirty-five patients (78%) had at least one significant postsurgical complication. Thirteen of 22 patients with loss of lordosis required corrective osteotomies. Other complications included pseudoarthrosis in ten patients and neurologic complications in five patients, four of which had complete recovery. Twenty-five patients required a total of 51 subsequent surgical procedures. Despite a 51% initially poor result and a high complication rate, the final results were good or fair in 93% of the patients. This change was primarily the result of successful subsequent surgical procedures for correction of loss of lordosis and pseudoarthrosis. The adult scoliosis patient should be fused to the sacrum only if the lumbosacral disc is clearly a source of pain or the degree of pelvic obliquity makes it necessary in the paralytic curve. Every effort must be made to carefully preserve the patient's lumbar lordosis. Better results were obtained by using segmental spinal fixation in the form of sublaminar wiring of double Luque rods.

Adult↗