Mid-term outcomes of the R3™ delta ceramic acetabular system in total hip arthroplasty.

BACKGROUND: Whilst bony fixation of hip replacement has stable solutions, there remains controversy over which bearing best optimizes longevity and function. Ceramic-on-ceramic (CoC) bearing combinations are associated with lower risk of revision due to aseptic loosening and dislocation. Evidence for long-term functional outcomes of modern, 4th generation CoC bearings is limited. The aim of this study was to analyze outcomes and complications of the R3™ Acetabular System (Smith & Nephew, Inc., Cordova, TN, USA) in combination with BIOLOX® Delta ceramic femoral head in patients undergoing primary total hip arthroplasty (THA). METHODS: Between June 2009 and May 2011, 175 patients (178 hips) were enrolled into a prospective, study at 6 sites in Europe and prospectively followed-up at 3 months and 1, 3, 5, and 7 years postoperative. RESULTS: Total WOMAC score improved from 63 (range, 22-91) preoperative to 8 (range, 0-8) at 1-year follow-up and remained unchanged at 7-year follow-up. Modified Harris hip score improved from 45 (range, 10-87) preoperative to 83 (range, 25-100) at 3 months, 91 (range, 42-100) at 1 year, and 92 (range, 46, 100) at 7 years. UCLA Activity Rating Scale score improved from 3.3 (range, 1-8) preoperative to 6.2 (range, 2-8) at 1 year; it marginally declined to 5.8 (range, 3-8) at 7-year follow-up. There were 4 trochanteric fractures and 5 patients died of unrelated reasons. Three hips were revised (2 periprosthetic fractures and 1 subluxation). The 7-year cumulative survival rate was 98.3%. CONCLUSION: Clinical and functional improvements of THA with CoC bearing are maintained at 7 years postoperative. TRIAL REGISTRATION: ClinicalTrials.Gov, NCT03566082 , Registered 10 January 2018-retrospectively registered.

Large head ceramic-on-ceramic bearing in primary total hip arthroplasty: average 3-year follow-up of a multicentre study.

BACKGROUND: Surgeons are increasingly using larger femoral head sizes in total hip arthroplasty (THA) to improve stability and reduce the rate of dislocation, 1 of the leading causes of revision surgery. Large ceramic head sizes up to 48 mm can now be used with monoblock acetabular components. National registries have shown promising results at short-term with large diameter ceramic-on-ceramic THA, with very low revision rates.This study reports on the average 3-year follow up of a press-fit monoblock large diameter acetabular shell with a pre-assembled ceramic liner, with emphasis on the radiographic outcome, complications related to the implantation of the cup, and the patient's clinical outcome. METHODS: 170 hips in 169 patients were reviewed at an average 38 ± 5.8 months following surgery. RESULTS: The radiographic review revealed no acetabular cup loosening, no osteolysis and no cup migration. 1 acetabular cup was revised for malposition. The patient clinical outcome and the satisfaction rate were excellent. At 3 years, 7.1% of patients complained of groin pain and 3.5% spontaneously reported hip joint generated noise. 1 patient sustained a non-recurrent traumatic hip dislocation 2 years post surgery. CONCLUSIONS: New technology should be introduced cautiously on the market. This is especially true for the large diameter ceramic monoblock acetabular component used in this study since it involves a new acetabular component design. At short term, we have not identified new modes of failure with this implant. Longer follow-up is still needed to assess the safety of large ceramic bearing in THA.

Survival of uncemented cups from a single manufacturer implanted from 1985 to 2013: Finnish Arthroplasty Register data.

INTRODUCTION: Total hip arthroplasty (THA) with uncemented implants has been a relatively common procedure in Finland during the recent decades. The most common brand of uncemented implants was chosen for further analysis to study the survivorship of this uncemented cup design in comparison to cemented references. PATIENTS, MATERIALS AND METHODS: Since 1980, The Finnish Arthroplasty Register has collected information on THAs on a national level. This study was based on information of THAs recorded in the Finnish Arthroplasty Register from 1985 to 2013. If patient had undergone bilateral THA, only the first one was included. Altogether, 49,289 THAs were included. RESULTS: The overall 10-year implant survivorship of uncemented implants was 84.3% (95% CI 83.5-85.0%) and of cemented implants 90.6% (90.2-90.0%). The 10-year survival of the contemporary uncemented implants was 90.8% (94.0-95.5%) and 88.5% (84.2-91.7%). The most recently introduced uncemented cup designs had good survivorship rates at 5 years; 10-year survival data are not yet available. CONCLUSIONS: We found that modern uncemented cup designs may provide good long-term survivorship rates comparable with the gold standard of cemented cups. However, polyethylene wear, liner problems and periosthetic osteolysis may still occur, also with modern uncemented acetabular components.

Poor 10-year survivorship of hip resurfacing arthroplasty.

Background and purpose - In a previous registry report, short-term implant survival of hip resurfacing arthroplasty (HRA) in Finland was found to be comparable to that of total hip arthroplasty (THA). Since then, it has become evident that adverse reactions to metal debris (ARMDs) may also be associated with HRA, not only with large-diameter head metal-on-metal THA. The aim of the study was to assess medium- to long-term survivorship of HRA based on the Finnish Arthroplasty Register (FAR). Patients and methods - 5,068 HRAs performed during the period 2001-2013 in Finland were included. Kaplan-Meier survival analysis was used to calculate survival probabilities and their 95% confidence intervals (CIs). Cox multiple regression, with adjustment for age, sex, diagnosis, femoral head size, and hospital volume was used to analyze implant survival of HRA devices with revision for any reason as endpoint. The reference group consisted of 6,485 uncemented Vision/Bimetric and ABG II THAs performed in Finland over the same time period. Results - The 8-year survival, with any revision as an endpoint, was 93% (CI: 92-94) for Birmingham Hip Resurfacing (BHR), 86% (CI: 78-94) for Corin, 91% (CI: 89-94) for ReCap, 92% (CI: 89-96) for Durom, and was 72% (CI: 69-76) for the Articular Surface Replacement (ASR). The 10-year survival, with any revision as an endpoint, for reference THAs was 92% (CI: 91-92) and for all HRAs it was 86% (CI: 84-87%). Female HRA patients had about twice the revision risk of male patients. ASR had an inferior outcome: the revision risk was 4-fold higher than for BHR, the reference implant. Interpretation - The 10-year implant survival of HRAs is 86% in Finland. According to new recommendations from NICE (The National Institute for Health and Care Excellence), an HRA/THA should have a revision rate of 5% or less at 10 years. None of the HRAs studied achieved this goal.

Is there more than one approach to evaluating the variability of surgeons' performance?

INTRODUCTION: To demonstrate that the variability found to be significant between surgeons' performances within a small group does not necessarily mean that this significance applies to the entire field of that specific type of surgery. It is common for inferences and recommendations for an entire field to be based on the variability within a small group of surgeons. The variability between groups usually remains unknown. METHODS: An analysis of variance was used to assess the statistical significance of the variability among surgeons' performances of a specific type of surgery within the studied sample. The intraclass correlation coefficient was used to investigate how large a segment of this variability can be explained by a surgeon-related factor for the entire surgeon population of a specific field. The topic was illustrated using data obtained from a group of seven surgeons who operated on the penetrating rotator cuff tears of 742 patients. RESULTS: There were statistically significant differences between seven surgeons in the improvement of pain and the range of shoulder joint motion. However, only a small (≤2%) and statistically non-significant part of this variability could be explained by a difference between surgeons when the results were interpolated across the entire population of shoulder surgeons. DISCUSSION AND CONCLUSION: Variability in performance within a group of surgeons performing a specific type of surgery cannot be generalized to include the performance of all surgeons doing the same type of surgery without additional statistical analyses.

The effect of tear size on the treatment outcome of operatively treated rotator cuff tears.

PURPOSE: The aim of this study was to evaluate the relationship between the tear size and the short-term clinical outcome of rotator cuff reconstruction. The hypothesis was that the size of the rotator cuff tear has a direct negative correlation with post-operative clinical outcome. METHODS: Five hundred and seventy-six consecutive shoulders with a primarily arthroscopically treated full-thickness rotator cuff tear were followed up. Rotator cuff tear size (anteroposterior dimension) was measured intraoperatively with an arthroscopic measuring probe. The Constant score was used as an outcome measure and was measured pre-operatively and 1-year post-operatively. RESULTS: Five hundred and sixty-nine patients (99 %) were available for 1-year follow-up. The mean age of patients was 59.6 (SD 9.6) years. There were 225 (40 %) female and 344 (60 %) male patients. The mean size of the rotator cuff tear was 25 mm (SD 18). The mean pre- and post-operative Constant score was 52.3 (SD 17.4) and 74.2 (SD 15.5), respectively (p < 0.0001). The intraoperatively detected tear size correlated significantly with the pre-operative Constant score (r = -0.20, p < 0.0001). Furthermore, there was even stronger and significant correlation between the tear size and the final post-operative Constant score (r = -0.36, p < 0.0001). The correlation was similar between the genders, but the Constant scores were significantly lower in women (p < 0.0001). The lowest scores were detected in tears with infraspinatus tendon involvement. CONCLUSIONS: The size of the rotator cuff tear linearly correlates with the Constant scores both pre- and post-operatively. The outcome of rotator cuff reconstruction is strongly related to the intraoperatively detected tear size. LEVEL OF EVIDENCE: Retrospective comparative register study, Level III.

Conservative treatment or surgery for shoulder impingement: systematic review and meta-analysis.

OBJECTIVE: To investigate the evidence on effectiveness of surgery for shoulder impingement compared with conservative treatment. DATA SOURCES: Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL and Science Citation Index databases were searched in March 2013 unrestricted by date or language. STUDY SELECTION: Controlled randomized (RCT) or quasi-randomized clinical trials comparing surgery and conservative treatment of shoulder impingement were included. DATA EXTRACTION: The methodological quality of each included trial was assessed according to the Cochrane Collaboration's domain-based evaluation framework. DATA SYNTHESIS: Of seven included RCTs, risk of systematic bias was considered to be low for two, high for four, and unclear for one RCT. The random-effect meta-analysis was conducted on four RCTs involving 347 subjects (173 surgically treated cases and 174 controls). There was no significant difference in changes in pain intensity between surgically and conservatively treated subjects (Hedges's g = 0.01 in favor of conservative treatment, 95% CI -0.27 to 0.30). CONCLUSION: Based on the review of seven RCTs, the evidence on effectiveness of surgical or conservative treatment of shoulder impingement was found to be limited. There was, however, moderate evidence that surgical treatment is not more effective than active exercises on reducing pain intensity caused by shoulder impingement. Implications for Rehabilitation Based on the review of seven RCTs, the evidence on effectiveness of surgical or conservative treatment of shoulder impingement was found to be limited. There was moderate evidence that surgical treatment is not more effective than active exercises on reducing pain intensity caused by shoulder impingement. Because of surgery's higher costs and susceptibility for complications compared with costs and risks of conservative treatment, conservative treatment can be recommended as a first choice of treatment of shoulder impingement in first or second grade.

Cancer incidence and cause-specific mortality in patients with metal-on-metal hip replacements in Finland.

BACKGROUND AND PURPOSE: Metal-on-metal hip implants have been widely used, especially in the USA, Australia, England and Wales, and Finland. We assessed risk of death and updated data on the risk of cancer related to metal-on-metal hip replacements. PATIENTS AND METHODS: A cohort of 10,728 metal-on-metal hip replacement patients and a reference cohort of 18,235 conventional total hip replacement patients were extracted from the Finnish Arthroplasty Register for the years 2001-2010. Data on incident cancer cases and causes of death until 2011 were obtained from the Finnish Cancer Registry and Statistics Finland. The relative risk of cancer and death were expressed as standardized incidence ratio (SIR) and standardized mortality ratio (SMR). SIR/SIR ratios and SMR/SMR ratios, and Poisson regression were used to compare the cancer risk and the risk of death between cohorts. RESULTS: The overall risk of cancer in the metal-on-metal cohort was not higher than that in the non-metal-on-metal cohort (RR = 0.91, 95% CI: 0.82-1.02). The risk of soft-tissue sarcoma and basalioma in the metal-on-metal cohort was higher than in the non-metal-on-metal cohort (SIR/SIR ratio = 2.6, CI: 1.02-6.4 for soft-tissue sarcoma; SIR/SIR ratio = 1.3, CI: 1.1-1.5 for basalioma). The overall risk of death in the metal-on-metal cohort was less than that in the non-metal-on-metal cohort (RR = 0.78, CI: 0.69-0.88). INTERPRETATION: The overall risk of cancer or risk of death because of cancer is not increased after metal-on-metal hip replacement. The well-patient effect and selection bias contribute substantially to the findings concerning mortality. Arthrocobaltism does not increase mortality in patients with metal-on-metal hip implants in the short term. However, metal-on-metal hip implants should not be considered safe until data with longer follow-up time are available.

Adverse reaction to metal debris after ReCap-M2A-Magnum large-diameter-head metal-on-metal total hip arthroplasty.

BACKGROUND AND PURPOSE: The clinical findings of adverse reaction to metal debris (ARMD) following large-diameter-head metal-on-metal total hip arthroplasty (LDH MoM THA) may include periarticular fluid collections, soft tissue masses, and gluteal muscle necrosis. The ReCap-M2a-Magnum LDH MoM THA was the most commonly used hip device at our institution from 2005 to 2012. We assessed the prevalence of and risk factors for ARMD with this device. METHODS: 74 patients (80 hips) had a ReCap-M2a-Magnum LDH MoM THA during the period August 2005 to December 2006. These patients were studied with hip MRI, serum chromium and cobalt ion measurements, the Oxford hip score questionnaire, and by clinical examination. The prevalence of ARMD was recorded and risk factors for ARMD were assessed using logistic regression models. The mean follow-up time was 6.0 (5.5-6.7) years. RESULTS: A revision operation due to ARMD was needed by 3 of 74 patients (3 of 80 hips). 8 additional patients (8 hips) had definite ARMD, but revision was not performed. 29 patients (32 hips) were considered to have a probable or possible ARMD. Altogether, 43 of 80 hips had a definite, probable, or possible ARMD and 34 patients (37 hips) were considered not to have ARMD. In 46 of 78 hips, MRI revealed a soft tissue mass or a collection of fluid (of any size). The symptoms clicking in the hip, local hip swelling, and a feeling of subluxation were associated with ARMD. INTERPRETATION: ARMD is common after ReCap-M2a-Magnum total hip arthroplasty, and we discourage the use of this device. Asymptomatic patients with a small fluid collection on MRI may not need instant revision surgery but must be followed up closely.

[Surgical treatment of shoulder instability]. / Olkanivelen epävakauden leikkaushoito TYKS:n kokemusten valossa.

Most commonly, shoulder instability results from a traumatic dislocation of the shoulder joint, usually happening to men under the age of 30. The first uncomplicated dislocation is treated conservatively. Instability refers to symptomatic instability of the shoulder joint, i.e. recurrent dislocations or fear of dislocation. Clinical examination and X-ray are usually sufficient for diagnosis. While mechanical instability of the shoulder joint is an indication for surgery, the operative technique should be selected in a patient-specific manner.

Effect of femoral head size on risk of revision for dislocation after total hip arthroplasty: a population-based analysis of 42,379 primary procedures from the Finnish Arthroplasty Register.

BACKGROUND AND PURPOSE: Previous population-based registry studies have shown that larger femoral head size is associated with reduced risk of revision for dislocation. However, the previous data have not included large numbers of hip resurfacing arthroplasties or large metal-on-metal (> 36-mm) femoral head arthroplasties. We evaluated the association between femoral component head size and the risk of revision for dislocation after THA by using Finnish Arthroplasty Register data. PATIENTS AND METHODS: 42,379 patients who were operated during 1996-2010 fulfilled our criteria. 18 different cup/stem combinations were included. The head-size groups studied (numbers of cases) were 28 mm (23,800), 32 mm (4,815), 36 mm (3,320), and > 36 mm (10,444). Other risk factors studied were sex, age group (18-49 years, 50-59 years, 60-69 years, 70-79 years, and > 80 years), and time period of operation (1996-2000, 2001-2005, 2006-2010). RESULTS: The adjusted risk ratio in the Cox model for a revision operation due to dislocation was 0.40 (95% CI: 0.26-0.62) for 32-mm head size, 0.41 (0.24-0.70) for 36-mm head size, and 0.09 (0.05-0.17) for > 36-mm head size compared to implants with a head size of 28 mm. INTERPRETATION: Larger femoral heads clearly reduce the risk of dislocation. The difference in using heads of > 36 mm as opposed to 28-mm heads for the overall revision rate at 10 years follow-up is about 2%. Thus, although attractive from a mechanical point of view, based on recent less favorable clinical outcome data on these large heads, consisting mainly of metal-on-metal prostheses, one should be cautious using these implants.

Electronic medical records for appropriate timing of arthroplasty.

OBJECTIVE: The objective of this study was to analyse whether electronic medical records (EMRs) of total hip and knee arthroplasty can be used to manage the optimal time of surgery. DESIGN: Retrospective registry study. SETTING: Data on waiting time for operation, age, gender, body mass index (BMI), operable condition pre-operatively and the functional scores at 3 and 12 months after arthroplasty were obtained from EMRs and from an electronic implant database. PARTICIPANTS: The participants of the study were 162 arthroplasty patients. RESULTS: An increase in waiting time of hip patients decreased significantly the change in functional scores at 3 months (P = 0.006, n = 56). The score reductions of older patients were more marked than of younger patients and of patients of normal weight compared with overweight patients. In patients undergoing knee arthroplasty, the association between a longer waiting time and profound change in functional score was statistically significant after 1 year (P = 0.03, n = 75). After adjustment of the results for pre-operative scores, age group, BMI class, American Society of Anesthesiologists class and gender, the waiting time turned out to affect only the scores of patients undergoing hip arthroplasty at 3 months post-operatively. CONCLUSIONS: Data from electronic patient entries complemented with data of the operable condition can be used for defining the optimal operation time with regard to the pre-operative condition of the patients. The implication of prolonged waiting times was not very profound, but elderly patients benefit from a short waiting time.

Risk of cancer with metal-on-metal hip replacements: population based study.

OBJECTIVE: To assess the risk of cancer associated with modern primary metal-on-metal hip replacements. DESIGN: Population based study. SETTING: Nationwide retrospective comparative register. PARTICIPANTS: 10,728 patients who underwent metal-on-metal total hip arthroplasty and 18,235 patients who underwent conventional metal-on-polyethylene, ceramic-on-polyethylene, and ceramic-on-ceramic total hip arthroplasty (the non-metal-on-metal cohort) in the Finnish Arthroplasty Register 2001-10. Data on cancer cases up to 2010 for these cohorts were extracted from the Finnish Cancer Registry. MAIN OUTCOME MEASURES: The relative risk of cancer was expressed as the ratio of observed to expected number of cases from the Finnish population--that is, the standardised incidence ratio. The relative risk of cancer in the metal-on-metal cohort compared with the non-metal-on-metal cohort was estimated with analyses of these ratios and Poisson regression. RESULTS: The overall risk of cancer in patients with metal-on-metal hip implants was similar to that in the Finnish population (378 observed v 400 expected, standardised incidence ratio 0.95, 95% confidence interval 0.85 to 1.04). The overall risk of cancer in patients with metal-on-metal hip implants was also no higher than in patients who had received non-metal-on-metal hip implants (relative risk 0.92, 0.81 to 1.05). CONCLUSIONS: Metal-on-metal hip replacements are not associated with an increased overall risk of cancer during a mean follow-up of four years.

Hip resurfacing arthroplasty: short-term survivorship of 4,401 hips from the Finnish Arthroplasty Register.

BACKGROUND AND PURPOSE: Population-based registry data from the Nordic Arthroplasty Register Association (NARA) and from the National Joint Register of England and Wales have revealed that the outcome after hip resurfacing arthroplasty (HRA) is inferior to that of conventional total hip arthroplasty (THA). We analyzed the short-term survival of 4,401 HRAs in the Finnish Arthroplasty Register. METHODS: We compared the revision risk of the 4,401 HRAs from the Register to that of 48,409 THAs performed during the same time period. The median follow-up time was 3.5 (0-9) years for HRAs and 3.9 (0-9) years for THAs. RESULTS: There was no statistically significant difference in revision risk between HRAs and THAs (RR = 0.93, 95% CI: 0.78-1.10). Female patients had about double the revision risk of male patients (RR = 2.0, CI: 1.4-2.7). Hospitals that had performed 100 or more HRA procedures had a lower revision risk than those with less than 100 HRAs (RR = 0.6, CI: 0.4-0.9). Articular Surface Replacement (ASR, DePuy) had inferior outcome with higher revision risk than the Birmingham Hip Resurfacing implant (BHR, Smith & Nephew), the reference implant (RR = 1.8, CI: 1.2-2.7). INTERPRETATION: We found that HRA had comparable short-term survivorship to THA at a nationwide level. Implant design had an influence on revision rates. ASR had higher revision risk. Low hospital procedure volume worsened the outcome of HRA. Female patients had twice the revision risk of male patients.

Cemented versus cementless total hip replacements in patients fifty-five years of age or older with rheumatoid arthritis.

BACKGROUND: results obtained from single-center studies indicate that a cemented total hip replacement is the treatment of choice for the management of patients over fifty-five years of age with rheumatoid arthritis. The aim of this study was to analyze population-based survival rates for cemented and cementless total hip replacements in patients aged fifty-five years or over with rheumatoid arthritis in Finland. METHODS: between 1980 and 2006, a total of 6000 primary total hip replacements performed for the management of rheumatoid arthritis in patients who were fifty-five years of age or older were entered in the Finnish Arthroplasty Registry. 4019 of them fulfilled our inclusion criteria and were subjected to analysis. The implants were classified into one of three possible groups: (1) a cementless group (a noncemented proximally porous-coated stem and a noncemented porous-coated press-fit cup), (2) a cemented group 1 (a cemented, loaded-taper stem combined with a cemented, all-polyethylene cup), or (3) a cemented group 2 (a cemented, composite-beam stem with a cemented, all-polyethylene cup). RESULTS: cementless stems and cups, analyzed separately, had a significantly lower risk of revision for aseptic loosening than cemented implants in patients who were fifty-five years of age or older with rheumatoid arthritis. The fifteen-year survival rate of cementless total hip replacements (80%) was comparable with the rates of the cemented groups (86% in cemented group 1 and 79% in cemented group 2) when revisions for any reason were used as the end point. CONCLUSIONS: cementless and cemented total hip replacements produced comparable long-term results in patients who were fifty-five years of age or older with rheumatoid arthritis. LEVEL OF EVIDENCE: therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.

Pharmacokinetics of intravenous paracetamol in elderly patients.

BACKGROUND AND OBJECTIVES: Intravenous paracetamol (N-acetyl-paraminophenol, acetaminophen) is a widely used nonopioid analgesic which has become popular in the treatment of pain in many patient groups, including the elderly. Although intravenous paracetamol has been studied widely in clinical analgesia studies, there is little information on its pharmacokinetics in the elderly. We designed this study to determine the pharmacokinetics of intravenous paracetamol in very old patients and to compare them with that of younger patients. We also considered the effect of adenosine triphosphate-binding cassette G2 protein (ABCG2) genotype and renal function on paracetamol pharmacokinetics in these patients. METHODS: We compared the pharmacokinetics of intravenous paracetamol in four groups of ten patients, aged 20-40, 60-70, 70-80 and 80-90 years, undergoing orthopaedic surgery. Paracetamol 1000 mg was given by infusion over 15 minutes. Plasma concentrations of paracetamol and its glucuronide and sulphate conjugates were measured for 24 hours with a high-performance liquid chromatographic method and ABCG2 genotype was determined. Glomerular filtration rate (GFR) was estimated from age, sex and serum creatinine of the patient. RESULTS: In the group aged 80-90 years, the mean value of the area under the plasma concentration-time curve extrapolated to infinity (AUC(∞)) of paracetamol was 54-68% higher than in the two youngest groups. Paracetamol clearance showed a statistically significant dependence on age group, whereas volume of distribution during elimination and elimination half-life were associated with age group and sex, respectively. Based on mean AUC(∞) of paracetamol glucuronide and paracetamol sulphate, the oldest patients had 1.3- to 1.5-fold greater exposure to these metabolites than patients aged 20-40 years. ABCG2 genotype did not affect paracetamol pharmacokinetics. There was a linear correlation between the values of AUC(∞) of paracetamol, its glucuronide and sulphate metabolites and GFR. CONCLUSION: Age and sex are important factors affecting the pharmacokinetics of paracetamol. The higher the age of the patient, the higher is the exposure to paracetamol. Female sex is associated with increased paracetamol concentrations but ABCG2 genotype does not seem to affect paracetamol pharmacokinetics. Trial registration number (EudraCT): 2006-001917-14.

Elimination of intravenous oxycodone in the elderly: a pharmacokinetic study in postoperative orthopaedic patients of different age groups.

BACKGROUND AND OBJECTIVE: Oxycodone is a widely used opioid analgesic, the global use of which has increased several-fold during the last decade. This study was designed to determine the effect of age on the pharmacokinetics of intravenous oxycodone, with special reference to renal function in elderly patients. METHODS: We compared the pharmacokinetics of 5 mg of intravenous oxycodone in four groups of 10-11 patients, aged 20-40, 60-70, 70-90 years, undergoing orthopaedic surgery. Plasma concentrations of oxycodone and its noroxycodone, oxymorphone and noroxymorphone metabolites were measured for 24 hours with a liquid chromatography-tandem mass spectrometric method. The cytochrome P450 (CYP) 2D6 genotype of the patients was determined. Glomerular filtration rate (GFR) was estimated on the basis of the age, sex and serum creatinine concentration of the patient. RESULTS: The pharmacokinetics of oxycodone showed age dependency. In the oldest group, the mean area under the plasma concentration-time curve from time zero to infinity (AUC(∞)) of oxycodone was 80% greater (p < 0.001) and the apparent total body clearance of the drug from plasma (CL) was 34% lower (p < 0.05) than in the youngest group. The mean AUC(∞) of oxycodone was also 30-41% greater in the oldest group than in the age groups of 60-70 and 70-80 years (p < 0.05). Oxycodone plasma concentrations from 8 hours post-dose were >2-fold higher (p < 0.01) in patients aged >80 years than in patients aged 20-40 years. Noroxycodone AUC(∞) was increased in the oldest group compared with patients aged 20-40 and 60-70 years (p < 0.05). There were no significant sex-related differences in any of the pharmacokinetic parameters. Because 37 of the 41 patients were extensive metabolizers through CYP2D6, the effect of the CYP2D6 genotype on oxycodone pharmacokinetics could not be properly assessed. There was a linear correlation between GFR and CL (p < 0.01, coefficient of determination [r(2)] = 0.26), volume of distribution at steady state (p < 0.05, r(2) = 0.19) and AUC(∞) (p < 0.01, r(2) = 0.29) of oxycodone. CONCLUSIONS: Age is an important factor affecting the pharmacokinetics of oxycodone. Following intravenous administration of oxycodone, patients aged >70 years are expected to have, on average, 40-80% higher exposure to oxycodone than young adult patients. Because oxycodone pharmacokinetics are greatly dependent on the age of the patient, it is important to titrate the analgesic dose individually, particularly in the elderly.

Repair of full-thickness rotator cuff tears is recommended regardless of tear size and age: a retrospective study of 218 patients.

Conservative therapy has been recommended for the treatment of a chronic cuff lesion with relatively good results. However, recent reports about operative treatment of cuff lesions have yielded more favorable results. Although the current literature seems to favor early treatment, there is an ongoing debate about the timing of the operation. During a 16-year period, 415 chronic full-thickness rotator cuff tears were operated on at our institution. The indication for operative treatment was persistent, severe or moderate pain at rest and impairment of shoulder function after initial conservative treatment. At follow-up, the symptoms were assessed by an interview, and all patients were clinically examined. Pain, function, range of active forward flexion, active abduction, strength (manual muscle testing), and patient satisfaction were recorded, and the results were evaluated by the University of California, Los Angeles shoulder rating scale. On the basis of our results, we recommend operative treatment of the rotator cuff for all cases in which the tear is full thickness, regardless of tear size, if patients have any symptoms, especially pain.

Results of early operative treatment of rotator cuff tears with acute symptoms.

The distinction among an acute tear, acute symptoms of a chronic tear, or the acute extension of an existing chronic tear is very difficult, if not impossible, to make. In general, operative treatment of lesions with a sudden onset has yielded favorable results in many studies. However, the timing of the operation for tears with an acute onset of symptoms is still a very controversial issue, as are the treatment options for chronic tears with acute symptoms. This study analyzes the follow-up results of early operative treatment of rotator cuff tears with an acute onset of symptoms, regardless of tear type. Twenty-nine patients with a sudden onset of symptoms and significant impairment of shoulder function had a full-thickness rotator cuff tear. The patients were operated on within 3 weeks from the beginning of the symptoms. Twenty-six patients underwent follow-up. The results were evaluated by use of the UCLA shoulder rating scale. At follow-up, 22 patients (85%) had no pain and 21 (81%) had returned to normal activities and had normal shoulder function. Active forward flexion averaged 51 degrees preoperatively and 167 degrees at follow-up. After repair of the tear, shoulder strength was normal in 22 of 26 shoulders (85%); 3 patients had fair strength, all after repair of a massive tear. Of the patients, 25 (96%) were satisfied with the result. The overall result was excellent in 20 patients (77%), good in 4 (15%), fair in 1 (4%), and poor in 1 (4%). Early operative treatment appears to be better for rotator cuff tears with a sudden onset of symptoms and poor function to achieve maximal return of shoulder function. With time, the tear may enlarge, and the cuff may lose its elasticity, thus making the late surgical repair more difficult or even impossible.