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Papers by Kenneth Pettine

Research paper thumbnail of Treating Cervical Disc Pathology with Bone Marrow Concentrate is Equal or Better than Fusion or Disc Replacement at Two-Year Follow-up

American journal of stem cell research, 2019

Objective: Millions of patients suffer chronic neck pain, headaches, inter-scapular pain, and rad... more Objective: Millions of patients suffer chronic neck pain, headaches, inter-scapular pain, and radiating arm pain from degenerated cervical discs. Operative options include cervical disc fusion or cervical artificial disc replacement. Patients with more than two degenerated discs have minimal surgical options. Study Design: This is a prospective nonrandomized study of the two- year follow-up results of injecting bone marrow concentrate (BMC) into symptomatic degenerated cervical discs compared to five FDA studies comparing Cervical Artificial Disc Replacement (CADR) to Anterior Cervical Fusion (ACF). The BMC study is class two data. The FDA studies are class one data. Methods: There were 182 patients in the BMC study. The 30- minute procedure involved aspirating 55ml of bone marrow from the iliac wing, concentrating this via centrifugation to a volume of 3ml, and then injecting 0.5ml of the bone marrow concentrate into each abnormal cervical disc. The FDA studies involved 788 CADR and 671 ACF one level patients. There were 225 two-level CADR and 105 fusion patients. All the studies had a 2 -year follow-up. Inclusion/exclusion requirements were similar in all the studies. All of the studies similarly compared clinical outcomes. Results: The average NDI improved 63% and VAS 67% in the BMC study. All scores had a P-value of less than 0.001. There was no difference in the clinical results comparing one, two, three, four or five-disc levels injected. There were no injection complications, and no patient was made worse. The overall success in the CADR one level studies was 74% with a reoperation rate of 3%. The one level ACF had a success of 65.3%, and reoperation of 6.7%. The two-level CADR had a success of 69.7% and a reoperation rate of 3%. The ACF patients had a success of 37.4% and a reoperation rate of 11%. Conclusions: These results indicate a BMC injection may be a reasonable non-surgical option for patients with symptomatic degenerated cervical discs, especially in the multi-level abnormal disc patients.

Research paper thumbnail of Metanalysis of Heterotopic Ossification (HO) Following Cervical Artificial Disc Replacement (CADR)

The Spine Journal, Sep 1, 2012

Research paper thumbnail of F.D.A. I.D.E. Prospective Randomized Comparison of Three Lumbar Artificial Disc Replacements (A.D.R.) with Minimum 3-Year Follow-Up

The Spine Journal, Sep 1, 2010

Research paper thumbnail of Clinical Significance of Hypermobility in Cervical Artificial Disc Replacements

The Spine Journal, Oct 1, 2011

Research paper thumbnail of Association of anabolic steroids and avascular necrosis of femoral heads

American Journal of Sports Medicine, 1991

Athletes, and even nonathletes, are using ever increasing doses of various steroids at younger ag... more Athletes, and even nonathletes, are using ever increasing doses of various steroids at younger ages for their perceived enhancement uf strength, performance, and appearance.5 ~ q There have been many studies on the effects of anabolic steroids. Although there are inconsistencies in the literature, it appears there can be significant increases in strength and muscle bulk in individuals taking anabolic steroids while on a continuous high-intensity weight training regimen.4, 7, 8, 11 13 Recognized side effects of anabolic steroids include: acne, abnormal liver function, peliosis hepatitis, hepatic tumors, changes in serum lipid levels, cardiovascular abnormalities, personality changes, and masculinization in females.1,2 Unlike glucocorticoids, to date there has not been a documented association between anabolic steroids and skeletal avascular necrosis. This is a case report of a weight lifter with prolonged anabolic steroid abuse and bilateral femoral head avascular necrosis.

Research paper thumbnail of POWERFUL SANGOMA +256773212554 TRADITIONAL SPIRITUAL HEALERS IN ENGLAND, Kuwait, Norway, Netherlands

Research paper thumbnail of Clinical and Radiographic Outcome of the NeoDisc Cervical Total Disc Replacement (TDR) at 2-Year Follow-up

The Spine Journal, Sep 1, 2010

Research paper thumbnail of A previously unreported cause of pain after total knee arthroplasty

Journal of Arthroplasty, 1986

Total knee arthroplasty achieves consistently excellent results in most patients. The most common... more Total knee arthroplasty achieves consistently excellent results in most patients. The most common causes of failure are loosening and infection. This article reviews the records of five patients in whom intraarticular fibrous tissue hypertrophy was the cause of pain after total knee arthroplasty. All of the patients had increasing pain and decreasing knee motion. Evaluation for loosening, malalignment, intraarticular debris, and infection gave negative results. Examination revealed a blocked range of motion and a palpable, tender, intraarticular mass. Injection of anesthetic relieved the symptoms. Surgical excision of the hypertrophic fibrous tissue relieved symptoms and increased knee range of motion. This cause of pain in the total knee arthroplasty patient is rare.

Research paper thumbnail of Elective Total Hip Arthroplasty in Patients Older Than 80 Years of Age

Clinical Orthopaedics and Related Research, May 1, 1991

Research paper thumbnail of Intervertebral disk arthroplasty

Research paper thumbnail of Arthroplastische Vorrichtung für Zwischenwirbelscheiben The intervertebral disk arthroplasty device

Research paper thumbnail of The Biologic Treatment of Osteoarthritis with Mesenchymal Stem Cell Exosomes: The Future is Now

HSOA Journal of Stem Cells Research, Development & Therapy, Apr 10, 2019

In patients with Osteoarthritis (OA), why is the correlation between what a patients imaging stud... more In patients with Osteoarthritis (OA), why is the correlation between what a patients imaging studies look like and their report of pain so low? Articular cartilage has no direct nerve or blood supply. Without direct innervation, cartilage is incapable of generating pain [1]. In contrast, the synovium and joint capsule are richly innervated and are likely the primary source of the pain in OA [2]. The synovial reaction in OA includes synovial hyperplasia, fibrosis, thickening of the synovial capsule, activated synoviocytes and in some cases lymphocytic infiltrate (B-and T-cells as well as plasma cells) [3-7]. The synovium is of obvious relevance as one of the most densely

Research paper thumbnail of Osteoid Osteoma and Osteoblastoma of the Spine

Research paper thumbnail of Five-Year Follow-Up of a Prospective, Randomized FDA IDE Trial Comparing Two Lumbar Total Disc Replacements: Clinical Outcome and Serum Ion Level Analysis for a Metal-on-Metal Device

The Spine Journal, Sep 1, 2013

BACKGROUND CONTEXT: Recently, results have been reported following the use of several cervical di... more BACKGROUND CONTEXT: Recently, results have been reported following the use of several cervical disc arthroplasty devices as an alternative to fusion after anterior cervical discectomy in the treatment of symptomatic cervical spondylosis. The PCM Cervical DiscÒ is a newly FDA-approved non-constrained device. PURPOSE: This is the first presentation of long-term (5-year) results from the US FDA IDE clinical trial of the PCM Cervical Disc versus anterior cervical discectomy and fusion (ACDF) with allograft and plate. STUDY DESIGN/SETTING: Prospective, randomized, multicenter, IRBapproved IDE clinical trial evaluating longitudinal outcomes over 5 years comparatively between arthroplasty and fusion groups. PATIENT SAMPLE: Patients 18-65 years of age with degenerative disc disease at one level between C3 and T1 with neurologic symptoms unresponsive to conservative care were included. A total of 404 patients were treated (214 PCM, 190 ACDF). The patient sample at 5 years included 160 patient in the PCM group and 124 in the ACDF group. OUTCOME MEASURES: Outcomes measures included neck disability index (NDI), neurological success (a motor, sensory, reflex composite), overall success (composite primary endpoint), flexion-extension range of motion (ROM), and rate of secondary surgeries at the operative level (revisions, reoperations, removals, and supplemental fixation). METHODS: NDI success defined as a minimum 20% improvement over baseline. Neurological success defined as maintenance or improvement in neurological status over baseline. Where appropriate, measures were tested for significant change from baseline to the 5-year postoperative follow-up visit, as well as differences between arthroplasty and fusion groups. RESULTS: At 5 years, the mean NDI score was 20.4 in the PCM group compared to 28.5 in the ACDF group (p50.001). Mean reduction in NDI score from baseline was 34.4 in the PCM group compared to 26.8 in the ACD group (p50.003). NDI success was achieved in 84.7% (133/ 157) of the PCM patients compared to 73.6% (92/125) in the ACDF patients (p50.025). Neurological success was achieved in 92.1% (140/152) of the PCM group and 88.2% (105/119) of the ACDF group (p50.305). ROM at the index level averaged 5.3 (range 0-16.1) for the PCM group and 0.5 (range 0-4.1) for the controls. In both groups, adjacent level ROM was generally consistent with the 2-, 3-and 4-year results. Overall success was achieved in 66.9% (107/160) of the PCM patients and 57.3% (71/124) of the ACDF patients (p50.108). Of the treated patients, secondary surgeries at the operative level (only reoperations and removals were observed) have been performed on 7.9% (17/214) of the PCM patients and on 7.4% (14/190) of the control patients (p50.854). CONCLUSIONS: This randomized, prospective FDA IDE study found that the treatment of symptomatic single-level cervical spondylosis with the PCM device maintained motion and continued to achieve clinical

Research paper thumbnail of P63. Prospective Randomized Comparison of Three Lumbar Artificial Disc Replacements (ADR)

The Spine Journal, Sep 1, 2008

Research paper thumbnail of P5. A Prospective Randomized Comparison of Two Lumbar Total Disc Replacements: Results at 24-Month Follow-Up

The Spine Journal, Oct 1, 2009

Research paper thumbnail of Study Comparing Mesenchymal Precursor Cells and Autogenous Iliac Crest Bone Graft for Lumbar Interbody Fusion in a Randomized Controlled Phase 2 FDA Clinical Trial

The Spine Journal, Sep 1, 2013

Research paper thumbnail of Comparison of Outcomes between Artificial Disc Replacements and Bone Marrow Concentrate Injections at the Same Clinic for Chronic Discogenic Low Back Pain

The Spine Journal, Oct 1, 2016

Research paper thumbnail of 22. Why Lumbar Artificial Disc Replacements (ADR) Fail: Home Run or Strike Out?

The Spine Journal, Sep 1, 2008

Research paper thumbnail of Prophylactic Cerclage: A Method of Preventing Femur Fracture in Uncemented Total Hip Arthroplasty

Orthopedics, Feb 1, 1992

The incidence of femur fracture in non-cemented hip arthroplasty has been reported to be between ... more The incidence of femur fracture in non-cemented hip arthroplasty has been reported to be between 4.1% and 27.8%. To quantitate the hoop stress generated during insertion of a femoral broach in total hip arthroplasty and determine the effect of cerclage with both braided cable and wire, we harvested 14 pairs of embalmed cadaver femurs. These were reamed and broached to duplicate the surgical technique of inserting a straight non-cemented femoral component. Group one consisted of eight matched cadaver femurs which were tested using a single 2.0 mm chrome-cobalt cable placed around the calcar of one femur, with the other serving as a control. Group two consisted of five matched cadaver femurs which were tested using a single 18 gauge cerclage wire in the same manner. In group one, the femurs serving as controls were found to have a mean microstrain of (1425.00 +/- 1180.19). The eight femurs tested with a 2 mm cable were determined to have a mean microstrain of (4179 +/- 2853.89). In group two, the femurs serving as controls were found to have a mean microstrain of (962.60 +/- 956.78). The five femurs in group two tested with a cerclage wire were determined to have a mean microstrain of (1112.00 +/- 975.66). Using a paired t-test, statistical significance was achieved with a confidence level of P less than or equal to .01 in group one. Prophylactic wiring of the proximal femur with 2 mm cable increases the hoop stress resistance and, therefore, should decrease the incidence of intraoperative femur fractures in uncemented total hip arthroplasty.

Research paper thumbnail of Treating Cervical Disc Pathology with Bone Marrow Concentrate is Equal or Better than Fusion or Disc Replacement at Two-Year Follow-up

American journal of stem cell research, 2019

Objective: Millions of patients suffer chronic neck pain, headaches, inter-scapular pain, and rad... more Objective: Millions of patients suffer chronic neck pain, headaches, inter-scapular pain, and radiating arm pain from degenerated cervical discs. Operative options include cervical disc fusion or cervical artificial disc replacement. Patients with more than two degenerated discs have minimal surgical options. Study Design: This is a prospective nonrandomized study of the two- year follow-up results of injecting bone marrow concentrate (BMC) into symptomatic degenerated cervical discs compared to five FDA studies comparing Cervical Artificial Disc Replacement (CADR) to Anterior Cervical Fusion (ACF). The BMC study is class two data. The FDA studies are class one data. Methods: There were 182 patients in the BMC study. The 30- minute procedure involved aspirating 55ml of bone marrow from the iliac wing, concentrating this via centrifugation to a volume of 3ml, and then injecting 0.5ml of the bone marrow concentrate into each abnormal cervical disc. The FDA studies involved 788 CADR and 671 ACF one level patients. There were 225 two-level CADR and 105 fusion patients. All the studies had a 2 -year follow-up. Inclusion/exclusion requirements were similar in all the studies. All of the studies similarly compared clinical outcomes. Results: The average NDI improved 63% and VAS 67% in the BMC study. All scores had a P-value of less than 0.001. There was no difference in the clinical results comparing one, two, three, four or five-disc levels injected. There were no injection complications, and no patient was made worse. The overall success in the CADR one level studies was 74% with a reoperation rate of 3%. The one level ACF had a success of 65.3%, and reoperation of 6.7%. The two-level CADR had a success of 69.7% and a reoperation rate of 3%. The ACF patients had a success of 37.4% and a reoperation rate of 11%. Conclusions: These results indicate a BMC injection may be a reasonable non-surgical option for patients with symptomatic degenerated cervical discs, especially in the multi-level abnormal disc patients.

Research paper thumbnail of Metanalysis of Heterotopic Ossification (HO) Following Cervical Artificial Disc Replacement (CADR)

The Spine Journal, Sep 1, 2012

Research paper thumbnail of F.D.A. I.D.E. Prospective Randomized Comparison of Three Lumbar Artificial Disc Replacements (A.D.R.) with Minimum 3-Year Follow-Up

The Spine Journal, Sep 1, 2010

Research paper thumbnail of Clinical Significance of Hypermobility in Cervical Artificial Disc Replacements

The Spine Journal, Oct 1, 2011

Research paper thumbnail of Association of anabolic steroids and avascular necrosis of femoral heads

American Journal of Sports Medicine, 1991

Athletes, and even nonathletes, are using ever increasing doses of various steroids at younger ag... more Athletes, and even nonathletes, are using ever increasing doses of various steroids at younger ages for their perceived enhancement uf strength, performance, and appearance.5 ~ q There have been many studies on the effects of anabolic steroids. Although there are inconsistencies in the literature, it appears there can be significant increases in strength and muscle bulk in individuals taking anabolic steroids while on a continuous high-intensity weight training regimen.4, 7, 8, 11 13 Recognized side effects of anabolic steroids include: acne, abnormal liver function, peliosis hepatitis, hepatic tumors, changes in serum lipid levels, cardiovascular abnormalities, personality changes, and masculinization in females.1,2 Unlike glucocorticoids, to date there has not been a documented association between anabolic steroids and skeletal avascular necrosis. This is a case report of a weight lifter with prolonged anabolic steroid abuse and bilateral femoral head avascular necrosis.

Research paper thumbnail of POWERFUL SANGOMA +256773212554 TRADITIONAL SPIRITUAL HEALERS IN ENGLAND, Kuwait, Norway, Netherlands

Research paper thumbnail of Clinical and Radiographic Outcome of the NeoDisc Cervical Total Disc Replacement (TDR) at 2-Year Follow-up

The Spine Journal, Sep 1, 2010

Research paper thumbnail of A previously unreported cause of pain after total knee arthroplasty

Journal of Arthroplasty, 1986

Total knee arthroplasty achieves consistently excellent results in most patients. The most common... more Total knee arthroplasty achieves consistently excellent results in most patients. The most common causes of failure are loosening and infection. This article reviews the records of five patients in whom intraarticular fibrous tissue hypertrophy was the cause of pain after total knee arthroplasty. All of the patients had increasing pain and decreasing knee motion. Evaluation for loosening, malalignment, intraarticular debris, and infection gave negative results. Examination revealed a blocked range of motion and a palpable, tender, intraarticular mass. Injection of anesthetic relieved the symptoms. Surgical excision of the hypertrophic fibrous tissue relieved symptoms and increased knee range of motion. This cause of pain in the total knee arthroplasty patient is rare.

Research paper thumbnail of Elective Total Hip Arthroplasty in Patients Older Than 80 Years of Age

Clinical Orthopaedics and Related Research, May 1, 1991

Research paper thumbnail of Intervertebral disk arthroplasty

Research paper thumbnail of Arthroplastische Vorrichtung für Zwischenwirbelscheiben The intervertebral disk arthroplasty device

Research paper thumbnail of The Biologic Treatment of Osteoarthritis with Mesenchymal Stem Cell Exosomes: The Future is Now

HSOA Journal of Stem Cells Research, Development & Therapy, Apr 10, 2019

In patients with Osteoarthritis (OA), why is the correlation between what a patients imaging stud... more In patients with Osteoarthritis (OA), why is the correlation between what a patients imaging studies look like and their report of pain so low? Articular cartilage has no direct nerve or blood supply. Without direct innervation, cartilage is incapable of generating pain [1]. In contrast, the synovium and joint capsule are richly innervated and are likely the primary source of the pain in OA [2]. The synovial reaction in OA includes synovial hyperplasia, fibrosis, thickening of the synovial capsule, activated synoviocytes and in some cases lymphocytic infiltrate (B-and T-cells as well as plasma cells) [3-7]. The synovium is of obvious relevance as one of the most densely

Research paper thumbnail of Osteoid Osteoma and Osteoblastoma of the Spine

Research paper thumbnail of Five-Year Follow-Up of a Prospective, Randomized FDA IDE Trial Comparing Two Lumbar Total Disc Replacements: Clinical Outcome and Serum Ion Level Analysis for a Metal-on-Metal Device

The Spine Journal, Sep 1, 2013

BACKGROUND CONTEXT: Recently, results have been reported following the use of several cervical di... more BACKGROUND CONTEXT: Recently, results have been reported following the use of several cervical disc arthroplasty devices as an alternative to fusion after anterior cervical discectomy in the treatment of symptomatic cervical spondylosis. The PCM Cervical DiscÒ is a newly FDA-approved non-constrained device. PURPOSE: This is the first presentation of long-term (5-year) results from the US FDA IDE clinical trial of the PCM Cervical Disc versus anterior cervical discectomy and fusion (ACDF) with allograft and plate. STUDY DESIGN/SETTING: Prospective, randomized, multicenter, IRBapproved IDE clinical trial evaluating longitudinal outcomes over 5 years comparatively between arthroplasty and fusion groups. PATIENT SAMPLE: Patients 18-65 years of age with degenerative disc disease at one level between C3 and T1 with neurologic symptoms unresponsive to conservative care were included. A total of 404 patients were treated (214 PCM, 190 ACDF). The patient sample at 5 years included 160 patient in the PCM group and 124 in the ACDF group. OUTCOME MEASURES: Outcomes measures included neck disability index (NDI), neurological success (a motor, sensory, reflex composite), overall success (composite primary endpoint), flexion-extension range of motion (ROM), and rate of secondary surgeries at the operative level (revisions, reoperations, removals, and supplemental fixation). METHODS: NDI success defined as a minimum 20% improvement over baseline. Neurological success defined as maintenance or improvement in neurological status over baseline. Where appropriate, measures were tested for significant change from baseline to the 5-year postoperative follow-up visit, as well as differences between arthroplasty and fusion groups. RESULTS: At 5 years, the mean NDI score was 20.4 in the PCM group compared to 28.5 in the ACDF group (p50.001). Mean reduction in NDI score from baseline was 34.4 in the PCM group compared to 26.8 in the ACD group (p50.003). NDI success was achieved in 84.7% (133/ 157) of the PCM patients compared to 73.6% (92/125) in the ACDF patients (p50.025). Neurological success was achieved in 92.1% (140/152) of the PCM group and 88.2% (105/119) of the ACDF group (p50.305). ROM at the index level averaged 5.3 (range 0-16.1) for the PCM group and 0.5 (range 0-4.1) for the controls. In both groups, adjacent level ROM was generally consistent with the 2-, 3-and 4-year results. Overall success was achieved in 66.9% (107/160) of the PCM patients and 57.3% (71/124) of the ACDF patients (p50.108). Of the treated patients, secondary surgeries at the operative level (only reoperations and removals were observed) have been performed on 7.9% (17/214) of the PCM patients and on 7.4% (14/190) of the control patients (p50.854). CONCLUSIONS: This randomized, prospective FDA IDE study found that the treatment of symptomatic single-level cervical spondylosis with the PCM device maintained motion and continued to achieve clinical

Research paper thumbnail of P63. Prospective Randomized Comparison of Three Lumbar Artificial Disc Replacements (ADR)

The Spine Journal, Sep 1, 2008

Research paper thumbnail of P5. A Prospective Randomized Comparison of Two Lumbar Total Disc Replacements: Results at 24-Month Follow-Up

The Spine Journal, Oct 1, 2009

Research paper thumbnail of Study Comparing Mesenchymal Precursor Cells and Autogenous Iliac Crest Bone Graft for Lumbar Interbody Fusion in a Randomized Controlled Phase 2 FDA Clinical Trial

The Spine Journal, Sep 1, 2013

Research paper thumbnail of Comparison of Outcomes between Artificial Disc Replacements and Bone Marrow Concentrate Injections at the Same Clinic for Chronic Discogenic Low Back Pain

The Spine Journal, Oct 1, 2016

Research paper thumbnail of 22. Why Lumbar Artificial Disc Replacements (ADR) Fail: Home Run or Strike Out?

The Spine Journal, Sep 1, 2008

Research paper thumbnail of Prophylactic Cerclage: A Method of Preventing Femur Fracture in Uncemented Total Hip Arthroplasty

Orthopedics, Feb 1, 1992

The incidence of femur fracture in non-cemented hip arthroplasty has been reported to be between ... more The incidence of femur fracture in non-cemented hip arthroplasty has been reported to be between 4.1% and 27.8%. To quantitate the hoop stress generated during insertion of a femoral broach in total hip arthroplasty and determine the effect of cerclage with both braided cable and wire, we harvested 14 pairs of embalmed cadaver femurs. These were reamed and broached to duplicate the surgical technique of inserting a straight non-cemented femoral component. Group one consisted of eight matched cadaver femurs which were tested using a single 2.0 mm chrome-cobalt cable placed around the calcar of one femur, with the other serving as a control. Group two consisted of five matched cadaver femurs which were tested using a single 18 gauge cerclage wire in the same manner. In group one, the femurs serving as controls were found to have a mean microstrain of (1425.00 +/- 1180.19). The eight femurs tested with a 2 mm cable were determined to have a mean microstrain of (4179 +/- 2853.89). In group two, the femurs serving as controls were found to have a mean microstrain of (962.60 +/- 956.78). The five femurs in group two tested with a cerclage wire were determined to have a mean microstrain of (1112.00 +/- 975.66). Using a paired t-test, statistical significance was achieved with a confidence level of P less than or equal to .01 in group one. Prophylactic wiring of the proximal femur with 2 mm cable increases the hoop stress resistance and, therefore, should decrease the incidence of intraoperative femur fractures in uncemented total hip arthroplasty.