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John W Noble - One of the best experts on this subject based on the ideXlab platform.

  • results of the first u s fda approved Hip Resurfacing Device at 10 year follow up
    Journal of Bone and Joint Surgery American Volume, 2021
    Co-Authors: Vinay Bhal, Lawrence R Housman, John Masonis, John W Noble, Robert H Hopper, Anderson C Engh
    Abstract:

    BACKGROUND The BIRMINGHAM Hip Resurfacing (BHR) system is a metal-on-metal Hip implant system approved by the U.S. Food and Drug Administration in 2006. The approval required a multicenter, prospective, post-market-approval study. Our purpose is to report the current results at 10 years of follow-up. METHODS Between October 2006 and December 2009, 280 primary BHR procedures were performed at 5 sites. Outcome measures included Kaplan-Meier survivorsHip, reasons for revision, radiographic component stability and osteolysis, Harris Hip scores, and metal levels including cobalt and chromium. The mean age at the time of the procedure was 51.3 ± 7.1 years, 74% (206) of 280 BHRs were implanted in male patients, the mean body mass index was 27.8 ± 4.4 kg/m2, and 95% (265) of 280 Hips had a primary diagnosis of osteoarthritis. The mean follow-up among all 280 Hips was 9.0 ± 2.5 years. Prior to 10-year follow-up, 20 Hips were revised and 5 patients representing 5 Hips had died. Among the remaining 255 Hips, 218 (85%) met the minimum follow-up of 10 years. RESULTS The 10-year survival free from all-cause component revision was 92.9% (95% confidence interval [CI], 89.8% to 96.1%) for all Hips and 96.0% (95% CI, 93.1% to 98.9%) among male patients <65 years old at the time of the procedure. Reasons for revision included femoral loosening (n = 5), femoral neck fracture (n = 3), pseudotumor (n = 3), osteolysis (n = 2), and acetabular loosening (n = 1), as well as 6 revisions for a combination of pain, noise, or metal levels. Among unrevised Hips, the median Harris Hip score improved from preoperatively (59) to 1 year postoperatively (99; p < 0.001) and remained stable through 10 years postoperatively (99; p = 0.08). Radiographically, 5% (10) of 218 unrevised Hips had osteolysis with no component migration. Median metal levels had increased at 1 year postoperatively (cobalt: from 0.12 ppb preoperatively to 1.5 ppb at 1 year postoperatively, p < 0.001; chromium: from 0.6 ppb preoperatively to 1.7 ppb at 1 year postoperatively, p < 0.001), then remained stable through 5 years before slightly decreasing at 10 years postoperatively (cobalt: 1.3 ppb, p < 0.001; chromium: 1.4 ppb, p < 0.001). CONCLUSIONS This prospective, multicenter, post-market-approval study demonstrated that the BHR implant system is safe and effective through 10 years of follow-up, particularly among young male patients. LEVEL OF EVIDENCE Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

  • five year results of the first us fda approved Hip Resurfacing Device
    Journal of Arthroplasty, 2014
    Co-Authors: Lawrence R Housman, John Masonis, John W Noble, Anderson C Engh
    Abstract:

    Abstract A prospective, multi-center postmarket approval study has been ongoing since May 2006 to assess safety and efficacy of the first US FDA approved Hip Resurfacing implant. 265 patients have been enrolled at five study sites. The average age of the patients is 51.3years. There have been 7 revisions (2.4%) in the cohort to date. K–M survival curves for the cohort are 97.6% at 5years. There is a trend toward a gender difference in implant survivorsHip, with 98.6% of men and 94.7% of women free from revision. Metal ion analysis revealed median cobalt and chromium levels of 1.5ppb and 1.7ppb at 1year. In this prospective US study, the Birmingham Hip Resurfacing implant is demonstrating results comparable to those in the literature.

  • five year results of a post market approval study of the first us fda approved Hip Resurfacing Device a difference in survival between male and female gender
    Journal of Bone and Joint Surgery-british Volume, 2013
    Co-Authors: Lawrence R Housman, John Masonis, John W Noble
    Abstract:

    Background Post-market surveillance is necessary to ensure the safety and efficacy of newly introduced technologies and implants. The Birmingham Hip Resurfacing (Smith and Nephew, Inc., Memphis, TN) was the first Hip Resurfacing implant approved for use by the US FDA in May 2006. A prospective, multi-center postmarket approval study has been in progress to assess safety and efficacy of this implant. Methods Patients meeting inclusion criteria were enrolled at five sites. Clinical evaluation and radiographs were obtained at 3 months and 1 year, and annually thereafter for a total of 10 years. Blood metal ion levels were measured at 1 year and 4 years. Results 265 patients have been enrolled thus far with 193 males; 28 patients have had bilateral procedures. The average age of the patients is 51.3 years (range 22–72). There have been 7 revisions (2.4%) in the entire cohort to date: 2 were for femoral neck fracture, 2 were for acetabular loosening; 1 was for femoral head osteonecrosis; 1 was revised on the day of surgery for errant implant placement; and 1 was for pseudotumor. K-M survival curves for the cohort are 97.8% at 5 years (Figure 1); men had 99% survival, while women had 94.5%. Whole blood metal ion analysis revealed a median cobalt and chromium levels of 1.5 ppb and 1.7 ppb at 1 year. There was a significant difference between the metal levels in men and women, however women also had smaller component sizes. Furthermore, a significantly higher percentage of female patients had outlier metal ion levels > 7 ppb. Conclusions This Hip Resurfacing Device has demonstrated safety and efficacy comparable to THR, in this multicenter postmarket approval study. A gender difference in the survival rate and median metal ion levels does exist; therefore, it is important to continue close monitoring of this cohort to determine longer term results.

Lawrence R Housman - One of the best experts on this subject based on the ideXlab platform.

  • results of the first u s fda approved Hip Resurfacing Device at 10 year follow up
    Journal of Bone and Joint Surgery American Volume, 2021
    Co-Authors: Vinay Bhal, Lawrence R Housman, John Masonis, John W Noble, Robert H Hopper, Anderson C Engh
    Abstract:

    BACKGROUND The BIRMINGHAM Hip Resurfacing (BHR) system is a metal-on-metal Hip implant system approved by the U.S. Food and Drug Administration in 2006. The approval required a multicenter, prospective, post-market-approval study. Our purpose is to report the current results at 10 years of follow-up. METHODS Between October 2006 and December 2009, 280 primary BHR procedures were performed at 5 sites. Outcome measures included Kaplan-Meier survivorsHip, reasons for revision, radiographic component stability and osteolysis, Harris Hip scores, and metal levels including cobalt and chromium. The mean age at the time of the procedure was 51.3 ± 7.1 years, 74% (206) of 280 BHRs were implanted in male patients, the mean body mass index was 27.8 ± 4.4 kg/m2, and 95% (265) of 280 Hips had a primary diagnosis of osteoarthritis. The mean follow-up among all 280 Hips was 9.0 ± 2.5 years. Prior to 10-year follow-up, 20 Hips were revised and 5 patients representing 5 Hips had died. Among the remaining 255 Hips, 218 (85%) met the minimum follow-up of 10 years. RESULTS The 10-year survival free from all-cause component revision was 92.9% (95% confidence interval [CI], 89.8% to 96.1%) for all Hips and 96.0% (95% CI, 93.1% to 98.9%) among male patients <65 years old at the time of the procedure. Reasons for revision included femoral loosening (n = 5), femoral neck fracture (n = 3), pseudotumor (n = 3), osteolysis (n = 2), and acetabular loosening (n = 1), as well as 6 revisions for a combination of pain, noise, or metal levels. Among unrevised Hips, the median Harris Hip score improved from preoperatively (59) to 1 year postoperatively (99; p < 0.001) and remained stable through 10 years postoperatively (99; p = 0.08). Radiographically, 5% (10) of 218 unrevised Hips had osteolysis with no component migration. Median metal levels had increased at 1 year postoperatively (cobalt: from 0.12 ppb preoperatively to 1.5 ppb at 1 year postoperatively, p < 0.001; chromium: from 0.6 ppb preoperatively to 1.7 ppb at 1 year postoperatively, p < 0.001), then remained stable through 5 years before slightly decreasing at 10 years postoperatively (cobalt: 1.3 ppb, p < 0.001; chromium: 1.4 ppb, p < 0.001). CONCLUSIONS This prospective, multicenter, post-market-approval study demonstrated that the BHR implant system is safe and effective through 10 years of follow-up, particularly among young male patients. LEVEL OF EVIDENCE Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

  • five year results of the first us fda approved Hip Resurfacing Device
    Journal of Arthroplasty, 2014
    Co-Authors: Lawrence R Housman, John Masonis, John W Noble, Anderson C Engh
    Abstract:

    Abstract A prospective, multi-center postmarket approval study has been ongoing since May 2006 to assess safety and efficacy of the first US FDA approved Hip Resurfacing implant. 265 patients have been enrolled at five study sites. The average age of the patients is 51.3years. There have been 7 revisions (2.4%) in the cohort to date. K–M survival curves for the cohort are 97.6% at 5years. There is a trend toward a gender difference in implant survivorsHip, with 98.6% of men and 94.7% of women free from revision. Metal ion analysis revealed median cobalt and chromium levels of 1.5ppb and 1.7ppb at 1year. In this prospective US study, the Birmingham Hip Resurfacing implant is demonstrating results comparable to those in the literature.

  • five year results of a post market approval study of the first us fda approved Hip Resurfacing Device a difference in survival between male and female gender
    Journal of Bone and Joint Surgery-british Volume, 2013
    Co-Authors: Lawrence R Housman, John Masonis, John W Noble
    Abstract:

    Background Post-market surveillance is necessary to ensure the safety and efficacy of newly introduced technologies and implants. The Birmingham Hip Resurfacing (Smith and Nephew, Inc., Memphis, TN) was the first Hip Resurfacing implant approved for use by the US FDA in May 2006. A prospective, multi-center postmarket approval study has been in progress to assess safety and efficacy of this implant. Methods Patients meeting inclusion criteria were enrolled at five sites. Clinical evaluation and radiographs were obtained at 3 months and 1 year, and annually thereafter for a total of 10 years. Blood metal ion levels were measured at 1 year and 4 years. Results 265 patients have been enrolled thus far with 193 males; 28 patients have had bilateral procedures. The average age of the patients is 51.3 years (range 22–72). There have been 7 revisions (2.4%) in the entire cohort to date: 2 were for femoral neck fracture, 2 were for acetabular loosening; 1 was for femoral head osteonecrosis; 1 was revised on the day of surgery for errant implant placement; and 1 was for pseudotumor. K-M survival curves for the cohort are 97.8% at 5 years (Figure 1); men had 99% survival, while women had 94.5%. Whole blood metal ion analysis revealed a median cobalt and chromium levels of 1.5 ppb and 1.7 ppb at 1 year. There was a significant difference between the metal levels in men and women, however women also had smaller component sizes. Furthermore, a significantly higher percentage of female patients had outlier metal ion levels > 7 ppb. Conclusions This Hip Resurfacing Device has demonstrated safety and efficacy comparable to THR, in this multicenter postmarket approval study. A gender difference in the survival rate and median metal ion levels does exist; therefore, it is important to continue close monitoring of this cohort to determine longer term results.

Anderson C Engh - One of the best experts on this subject based on the ideXlab platform.

  • results of the first u s fda approved Hip Resurfacing Device at 10 year follow up
    Journal of Bone and Joint Surgery American Volume, 2021
    Co-Authors: Vinay Bhal, Lawrence R Housman, John Masonis, John W Noble, Robert H Hopper, Anderson C Engh
    Abstract:

    BACKGROUND The BIRMINGHAM Hip Resurfacing (BHR) system is a metal-on-metal Hip implant system approved by the U.S. Food and Drug Administration in 2006. The approval required a multicenter, prospective, post-market-approval study. Our purpose is to report the current results at 10 years of follow-up. METHODS Between October 2006 and December 2009, 280 primary BHR procedures were performed at 5 sites. Outcome measures included Kaplan-Meier survivorsHip, reasons for revision, radiographic component stability and osteolysis, Harris Hip scores, and metal levels including cobalt and chromium. The mean age at the time of the procedure was 51.3 ± 7.1 years, 74% (206) of 280 BHRs were implanted in male patients, the mean body mass index was 27.8 ± 4.4 kg/m2, and 95% (265) of 280 Hips had a primary diagnosis of osteoarthritis. The mean follow-up among all 280 Hips was 9.0 ± 2.5 years. Prior to 10-year follow-up, 20 Hips were revised and 5 patients representing 5 Hips had died. Among the remaining 255 Hips, 218 (85%) met the minimum follow-up of 10 years. RESULTS The 10-year survival free from all-cause component revision was 92.9% (95% confidence interval [CI], 89.8% to 96.1%) for all Hips and 96.0% (95% CI, 93.1% to 98.9%) among male patients <65 years old at the time of the procedure. Reasons for revision included femoral loosening (n = 5), femoral neck fracture (n = 3), pseudotumor (n = 3), osteolysis (n = 2), and acetabular loosening (n = 1), as well as 6 revisions for a combination of pain, noise, or metal levels. Among unrevised Hips, the median Harris Hip score improved from preoperatively (59) to 1 year postoperatively (99; p < 0.001) and remained stable through 10 years postoperatively (99; p = 0.08). Radiographically, 5% (10) of 218 unrevised Hips had osteolysis with no component migration. Median metal levels had increased at 1 year postoperatively (cobalt: from 0.12 ppb preoperatively to 1.5 ppb at 1 year postoperatively, p < 0.001; chromium: from 0.6 ppb preoperatively to 1.7 ppb at 1 year postoperatively, p < 0.001), then remained stable through 5 years before slightly decreasing at 10 years postoperatively (cobalt: 1.3 ppb, p < 0.001; chromium: 1.4 ppb, p < 0.001). CONCLUSIONS This prospective, multicenter, post-market-approval study demonstrated that the BHR implant system is safe and effective through 10 years of follow-up, particularly among young male patients. LEVEL OF EVIDENCE Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

  • five year results of the first us fda approved Hip Resurfacing Device
    Journal of Arthroplasty, 2014
    Co-Authors: Lawrence R Housman, John Masonis, John W Noble, Anderson C Engh
    Abstract:

    Abstract A prospective, multi-center postmarket approval study has been ongoing since May 2006 to assess safety and efficacy of the first US FDA approved Hip Resurfacing implant. 265 patients have been enrolled at five study sites. The average age of the patients is 51.3years. There have been 7 revisions (2.4%) in the cohort to date. K–M survival curves for the cohort are 97.6% at 5years. There is a trend toward a gender difference in implant survivorsHip, with 98.6% of men and 94.7% of women free from revision. Metal ion analysis revealed median cobalt and chromium levels of 1.5ppb and 1.7ppb at 1year. In this prospective US study, the Birmingham Hip Resurfacing implant is demonstrating results comparable to those in the literature.

John Masonis - One of the best experts on this subject based on the ideXlab platform.

  • results of the first u s fda approved Hip Resurfacing Device at 10 year follow up
    Journal of Bone and Joint Surgery American Volume, 2021
    Co-Authors: Vinay Bhal, Lawrence R Housman, John Masonis, John W Noble, Robert H Hopper, Anderson C Engh
    Abstract:

    BACKGROUND The BIRMINGHAM Hip Resurfacing (BHR) system is a metal-on-metal Hip implant system approved by the U.S. Food and Drug Administration in 2006. The approval required a multicenter, prospective, post-market-approval study. Our purpose is to report the current results at 10 years of follow-up. METHODS Between October 2006 and December 2009, 280 primary BHR procedures were performed at 5 sites. Outcome measures included Kaplan-Meier survivorsHip, reasons for revision, radiographic component stability and osteolysis, Harris Hip scores, and metal levels including cobalt and chromium. The mean age at the time of the procedure was 51.3 ± 7.1 years, 74% (206) of 280 BHRs were implanted in male patients, the mean body mass index was 27.8 ± 4.4 kg/m2, and 95% (265) of 280 Hips had a primary diagnosis of osteoarthritis. The mean follow-up among all 280 Hips was 9.0 ± 2.5 years. Prior to 10-year follow-up, 20 Hips were revised and 5 patients representing 5 Hips had died. Among the remaining 255 Hips, 218 (85%) met the minimum follow-up of 10 years. RESULTS The 10-year survival free from all-cause component revision was 92.9% (95% confidence interval [CI], 89.8% to 96.1%) for all Hips and 96.0% (95% CI, 93.1% to 98.9%) among male patients <65 years old at the time of the procedure. Reasons for revision included femoral loosening (n = 5), femoral neck fracture (n = 3), pseudotumor (n = 3), osteolysis (n = 2), and acetabular loosening (n = 1), as well as 6 revisions for a combination of pain, noise, or metal levels. Among unrevised Hips, the median Harris Hip score improved from preoperatively (59) to 1 year postoperatively (99; p < 0.001) and remained stable through 10 years postoperatively (99; p = 0.08). Radiographically, 5% (10) of 218 unrevised Hips had osteolysis with no component migration. Median metal levels had increased at 1 year postoperatively (cobalt: from 0.12 ppb preoperatively to 1.5 ppb at 1 year postoperatively, p < 0.001; chromium: from 0.6 ppb preoperatively to 1.7 ppb at 1 year postoperatively, p < 0.001), then remained stable through 5 years before slightly decreasing at 10 years postoperatively (cobalt: 1.3 ppb, p < 0.001; chromium: 1.4 ppb, p < 0.001). CONCLUSIONS This prospective, multicenter, post-market-approval study demonstrated that the BHR implant system is safe and effective through 10 years of follow-up, particularly among young male patients. LEVEL OF EVIDENCE Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

  • five year results of the first us fda approved Hip Resurfacing Device
    Journal of Arthroplasty, 2014
    Co-Authors: Lawrence R Housman, John Masonis, John W Noble, Anderson C Engh
    Abstract:

    Abstract A prospective, multi-center postmarket approval study has been ongoing since May 2006 to assess safety and efficacy of the first US FDA approved Hip Resurfacing implant. 265 patients have been enrolled at five study sites. The average age of the patients is 51.3years. There have been 7 revisions (2.4%) in the cohort to date. K–M survival curves for the cohort are 97.6% at 5years. There is a trend toward a gender difference in implant survivorsHip, with 98.6% of men and 94.7% of women free from revision. Metal ion analysis revealed median cobalt and chromium levels of 1.5ppb and 1.7ppb at 1year. In this prospective US study, the Birmingham Hip Resurfacing implant is demonstrating results comparable to those in the literature.

  • five year results of a post market approval study of the first us fda approved Hip Resurfacing Device a difference in survival between male and female gender
    Journal of Bone and Joint Surgery-british Volume, 2013
    Co-Authors: Lawrence R Housman, John Masonis, John W Noble
    Abstract:

    Background Post-market surveillance is necessary to ensure the safety and efficacy of newly introduced technologies and implants. The Birmingham Hip Resurfacing (Smith and Nephew, Inc., Memphis, TN) was the first Hip Resurfacing implant approved for use by the US FDA in May 2006. A prospective, multi-center postmarket approval study has been in progress to assess safety and efficacy of this implant. Methods Patients meeting inclusion criteria were enrolled at five sites. Clinical evaluation and radiographs were obtained at 3 months and 1 year, and annually thereafter for a total of 10 years. Blood metal ion levels were measured at 1 year and 4 years. Results 265 patients have been enrolled thus far with 193 males; 28 patients have had bilateral procedures. The average age of the patients is 51.3 years (range 22–72). There have been 7 revisions (2.4%) in the entire cohort to date: 2 were for femoral neck fracture, 2 were for acetabular loosening; 1 was for femoral head osteonecrosis; 1 was revised on the day of surgery for errant implant placement; and 1 was for pseudotumor. K-M survival curves for the cohort are 97.8% at 5 years (Figure 1); men had 99% survival, while women had 94.5%. Whole blood metal ion analysis revealed a median cobalt and chromium levels of 1.5 ppb and 1.7 ppb at 1 year. There was a significant difference between the metal levels in men and women, however women also had smaller component sizes. Furthermore, a significantly higher percentage of female patients had outlier metal ion levels > 7 ppb. Conclusions This Hip Resurfacing Device has demonstrated safety and efficacy comparable to THR, in this multicenter postmarket approval study. A gender difference in the survival rate and median metal ion levels does exist; therefore, it is important to continue close monitoring of this cohort to determine longer term results.

Vinay Bhal - One of the best experts on this subject based on the ideXlab platform.

  • results of the first u s fda approved Hip Resurfacing Device at 10 year follow up
    Journal of Bone and Joint Surgery American Volume, 2021
    Co-Authors: Vinay Bhal, Lawrence R Housman, John Masonis, John W Noble, Robert H Hopper, Anderson C Engh
    Abstract:

    BACKGROUND The BIRMINGHAM Hip Resurfacing (BHR) system is a metal-on-metal Hip implant system approved by the U.S. Food and Drug Administration in 2006. The approval required a multicenter, prospective, post-market-approval study. Our purpose is to report the current results at 10 years of follow-up. METHODS Between October 2006 and December 2009, 280 primary BHR procedures were performed at 5 sites. Outcome measures included Kaplan-Meier survivorsHip, reasons for revision, radiographic component stability and osteolysis, Harris Hip scores, and metal levels including cobalt and chromium. The mean age at the time of the procedure was 51.3 ± 7.1 years, 74% (206) of 280 BHRs were implanted in male patients, the mean body mass index was 27.8 ± 4.4 kg/m2, and 95% (265) of 280 Hips had a primary diagnosis of osteoarthritis. The mean follow-up among all 280 Hips was 9.0 ± 2.5 years. Prior to 10-year follow-up, 20 Hips were revised and 5 patients representing 5 Hips had died. Among the remaining 255 Hips, 218 (85%) met the minimum follow-up of 10 years. RESULTS The 10-year survival free from all-cause component revision was 92.9% (95% confidence interval [CI], 89.8% to 96.1%) for all Hips and 96.0% (95% CI, 93.1% to 98.9%) among male patients <65 years old at the time of the procedure. Reasons for revision included femoral loosening (n = 5), femoral neck fracture (n = 3), pseudotumor (n = 3), osteolysis (n = 2), and acetabular loosening (n = 1), as well as 6 revisions for a combination of pain, noise, or metal levels. Among unrevised Hips, the median Harris Hip score improved from preoperatively (59) to 1 year postoperatively (99; p < 0.001) and remained stable through 10 years postoperatively (99; p = 0.08). Radiographically, 5% (10) of 218 unrevised Hips had osteolysis with no component migration. Median metal levels had increased at 1 year postoperatively (cobalt: from 0.12 ppb preoperatively to 1.5 ppb at 1 year postoperatively, p < 0.001; chromium: from 0.6 ppb preoperatively to 1.7 ppb at 1 year postoperatively, p < 0.001), then remained stable through 5 years before slightly decreasing at 10 years postoperatively (cobalt: 1.3 ppb, p < 0.001; chromium: 1.4 ppb, p < 0.001). CONCLUSIONS This prospective, multicenter, post-market-approval study demonstrated that the BHR implant system is safe and effective through 10 years of follow-up, particularly among young male patients. LEVEL OF EVIDENCE Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.