Pinloc or Hansson pins: a multicenter, randomized controlled study of 439 patients treated for femoral neck fractures.

Objectives: To compare the recently developed Hansson Pinloc system, which features 3 cylindrical parallel pins with hooks connected through a fixed-angle interlocking plate, with the Hansson Pin System (2 hook pins) for the treatment of femoral neck fractures. Design: One hundred fourteen patients with displaced femoral neck fractures and 325 patients with nondisplaced fractures from 9 orthopaedic centers were randomized to either Hansson Pinloc system or Hansson Pin System and followed for 2 years or until death. Age at inclusion was 50 years or older. Main Outcome Measurements: The primary outcome was failure (defined as early displacement, nonunion, symptomatic avascular necrosis, or deep infection). Secondary outcomes included revision surgery, Timed Up and Go (TUG) test and patient-reported outcome measures (PROMs: EQ-5D and WOMAC). Results: For nondisplaced fractures, the incidence of failure was 14% (23/169) in the Pinloc group and 16% (25/156) in the Hansson group. For displaced fractures, the analysis was stratified by age. Patients aged 50-69 years with displaced fractures showed a 2-year failure rate of 44% (17/39) in the Pinloc group versus 44% (16/36) in the Hansson group. For patients 70 years or older with displaced fractures, 33% (7/21) in the Pinloc group versus 22% (4/18) in the Hansson group failed. At 3 and 12 months, no clinically significant differences between treatment groups were found for EQ-5D-3L, WOMAC, or for the TUG in any fracture type or age group. Conclusions: There were no advantages for Pinloc in any of the studies aspects. Level of evidence: 1.

Risk factors during pregnancy and delivery for the development of Perthes' disease, a nationwide Swedish study of 2.1 million individuals.

BACKGROUND: To ascertain or disprove a correlation between suboptimal birth characteristics, breech position at delivery and development of Perthes' disease. METHODS: Study material was collected from nationwide registers regarding diagnoses, birth statistics and delivery data. As study population were included children with a diagnosis code for Perthes' disease who were alive and living in Sweden at age 13. Children with missing birth statistics were excluded. All children with no Perthes' disease diagnosis were used as control group. Both single and multiple logistical regression analyses were used to calculate OR for the included characteristics. RESULTS: Children in breech position had a higher risk for developing Perthes' disease. Children with Perthes' disease had also a higher probability of having been born pre-term, very pre-term or post-term. Lower than normal birth weight and a lower Apgar-score were also associated with Perthes' disease. CONCLUSIONS: There is a correlation between breech birth and development of Perthes' disease. There is also correlation to suboptimal birth characteristics. Despite our findings this should not be used for screening of Perthes' disease as the percentage of children who actually develop it is very low. Also, as of yet there is no possibility to diagnose Perthes' disease before the presence of skeletal changes. Our findings could be important in finding the cause of Perthes' disease and therefore developing better diagnostics, treatment and prevention.

An intact lacertus fibrosus improves strength after reinsertion of the distal biceps tendon.

PURPOSE: The importance of an intact lacertus fibrosus in distal biceps tendon injury is uncertain. This study aimed to assess long-term outcome following distal biceps tendon repair with focus on the significance of the lacertus fibrosus. METHODS: Thirty-six patients surgically treated for primary distal biceps tendon rupture were identified. Medical records were reviewed for patient demographics in addition to surgery-related data. All patients underwent a targeted clinical examination to assess elbow function and they completed a patient reported questionnaire. Radiographs were obtained at time of follow-up and evaluated for the presence of osteoarthritis (OA) and heterotopic ossification (HO). RESULTS: All patients were male. Median age at injury was 48 years (34-69) and median time of follow-up of was 71 months (23-165). All patients presented functional range of motion in the elbow. Median flexion strength was 76 Nm (45-135) (median 99% of uninjured side; range 66-128) with intact lacertus fibrosus and 70 Nm (43-124) (88%, 62-114) with torn lacertus fibrosus. Median supination strength was 6 Nm (3-11) (86%, range 36-144) with intact lacertus fibrosus and 8 Nm (3-17) (67%, 28-118) with torn lacertus fibrosus. No signs of OA were revealed, but three patients had major HO of which one patient had minor limitations in range of elbow motion. CONCLUSION: An intact lacertus fibrosus contributes to elbow strength and should be preserved in distal biceps tendon repair. LEVEL OF EVIDENCE: III.

Similar outcome of femoral neck fractures treated with Pinloc or Hansson Pins: 1-year data from a multicenter randomized clinical study on 439 patients.

Background and purpose - There are few reports on the efficiency of the Hansson Pinloc System (Pinloc) for fixation of femoral neck fractures. We compare Pinloc with the commonly used Hansson Pin System in a randomized clinical trial. The primary outcome measure is non-union or avascular necrosis within 2 years. We now report fracture failures and reoperations within the first year.Patients and methods - Between May 2014 and February 2017, 439 patients were included in the study. They were above 50 years of age and treated for a femoral neck fracture at 9 orthopedic departments in Sweden. They were randomized to either Pinloc or Hansson pins. The fractures were grouped as (a) non-displaced regardless of age, (b) displaced in patients < 70 years, or (c) ≥ 70 years old, but deemed unfit to undergo arthroplasty. Follow-up with radiographs and outpatient visits were at 3 and 12 months. Failure was defined as early displacement/non-union, symptomatic segmental collapse, or deep infection.Results - 1-year mortality was 11%. Of the 325 undisplaced fractures, 12% (21/169) Pinloc and 13% (20/156) Hansson pin patients had a failure during the first year. The reoperation frequencies were 10% (16/169) and 8% (13/156) respectively. For the 75 patients 50-69 years old with displaced fractures, 11/39 failures occurred in the Pinloc group and 11/36 in the Hansson group, and 8/39 versus 9/36 patients were reoperated. Among those 39 patients ≥ 70 years old, 7/21 failures occurred in the Pinloc group and 4/18 in the Hansson group. Reoperation frequencies were 4/21 for Pinloc and 3/18 for the Hansson pin patients. No statistically significant differences were found in any of the outcomes between the Pinloc and Hansson groups.Interpretation - We found no advantages with Pinloc regarding failure or reoperation frequencies in this 1-year follow-up.

Tensioning of the radioscaphocapitate and long radio-lunate ligaments for dynamic radiocarpal instability.

During 1994-2003, we treated 20 patients with post-traumatic radial-sided wrist pain and dynamic radiocarpal instability. After arthroscopy confirmed no disruption of the radioscaphocapitate ligament and an increased laxity of the ligament, we passed a strip of the radioscaphocapitate ligament through the long radio-lunate ligament. The rationale of this procedure was to increase tension of the two ligaments and to close the space of Poirier. Eighteen patients were assessed after 1-3.7 years (mean 2.5 years). Four patients were symptom-free and 11 patients were markedly improved. Fourteen patients were followed for 11-15 years; four patients were symptom-free and eight patients were markedly improved. Two reported unchanged symptoms and none was worse in the follow-up. Based on our findings, we suggest a cause of post-traumatic radial-sided wrist pain is laxity of the radiocarpal joint. We conclude that our surgical procedure increases tension in the radioscaphocapitate and long radio-lunate ligaments and decreases wrist pain at rest and during activity. LEVEL OF EVIDENCE: IV.

No effect of teriparatide on migration in total knee replacement.

Background and purpose - Aseptic loosening is a main cause of late revision in total knee replacement (TKR). Teriparatide, a recombinant parathyroid hormone (PTH), stimulates osteoblasts and has been suggested to improve cancellous bone healing in humans. This might also be relevant for prosthesis fixation. We used radiostereometric analysis (RSA) to investigate whether teriparatide influences prosthesis fixation. Early migration as measured by RSA can predict future loosening. Patients and methods - In a randomized controlled trial with blind evaluation, 50 patients with osteoarthritis of the knee were allocated to a teriparatide treatment group (Forsteo, 20 µg daily for 2 months postoperatively) or to an untreated control group. RSA was performed postoperatively and at 6 months, 12 months, and 24 months. The primary effect variable was maximal total point motion (MTPM) from 12 to 24 months. Results - Median maximal total point motion from 12 to 24 months was similar in the 2 groups (teriparatide: 0.14 mm, 10% and 90% percentiles: 0.08 and 0.24; control: 0.13 mm, 10% and 90% percentiles: 0.09 and 0.21). [Authors: this is perhaps better than using "10th" and "90th", which looks ugly in print./language editor] The 95% confidence interval for the difference between group means was -0.03 to 0.04 mm, indicating that no difference occurred. Interpretation - We found no effect of teriparatide on migration in total knee replacement. Other trials using the same dosing have suggested a positive effect of teriparatide on human cancellous fracture healing. Thus, the lack of effect on migration may have been due to something other than the dose. In a similar study in this issue of Acta Orthopaedica, we found that migration could be reduced with denosumab (Ledin et al. 2017 ). The difference in response between the anabolic substance teriparatide and the antiresorptive denosumab suggests that resorption has a more important role during the postoperative course than any deficit in bone formation.

Incidence of Perthes' disease in children born between 1973 and 1993.

Background and purpose - The incidence of Perthes' disease as reported in the literature varies widely between and within countries. The etiology of the disease is still unknown. Both environmental and genetic factors have been suggested to play a part in either causing the disease or increasing the susceptibility of an individual. We determined the incidence of Perthes' disease in Sweden and investigated possible relationships to parental socioeconomic status, ethnicity, marital status, mothers' age when giving birth, parity, number of siblings, and smoking habits. Patients and methods - Six Swedish population-based registers were used, together covering all children born in Sweden from 1973 through 1993. Results - The incidence of Perthes' disease in Sweden was 9.3 per 100,000 subjects. The ratio between boys and girls was 3.1:1. The educational level of the father and the mother of a child with Perthes' disease was lower than in the controls. The incidence was lower when the fathers were in the highest income bracket (above the 90th percentile). A higher proportion of parents of Nordic lineage had children with Perthes' disease than parental pairs with one or both who were not of such lineage. Interpretation - This study confirms that there is an association between the incidence of Perthes' disease and the socioeconomic status of the parents.

PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures. A randomized, controlled study of 40 patients.

BACKGROUND AND PURPOSE: There is solid evidence from animal experiments that parathyroid hormone (PTH) improves fracture healing. So far, only 3 papers on PTH and fracture repair in humans have been published. They suggest that PTH may enhance fracture healing, but the results do not appear to justify specific clinical recommendations. This study was carried out to determine whether teriparatide enhances fracture healing of proximal humerus fractures. PATIENTS AND METHODS: 40 post-menopausal women with a proximal humerus fracture were randomized to either daily injections with 20 µg teriparatide (PTH 1-34 (Forteo)) for 4 weeks or control treatment. At randomization, the patients were asked to assess how their pain at rest and during activity (visual analog scale (VAS)) and also function (DASH score) had been prior to the fracture. At 7 weeks and again at 3 months, their current state was assessed and the tests were repeated, including radiographs. 2 radiologists performed a blind qualitative scoring of the callus at 7 weeks. Callus formation was arbitrarily classified as "normal" or "better". RESULTS: 39 patients completed the follow-up. The radiographic assessment showed a correct correlation, "better" in the teriparatide group and "normal" in the control group, in 21 of the 39 cases. There were no statistically significant differences in pain, in use of strong analgesics, or in function between the groups at the follow-up examinations. INTERPRETATION: There were no radiographic signs of enhanced healing or improved clinical results in the group treated with teriparatide.

Internal fixation compared with total hip replacement for displaced femoral neck fractures: a minimum fifteen-year follow-up study of a previously reported randomized trial.

BACKGROUND: Prospective randomized studies comparing internal fixation and a cemented hip replacement in the treatment of displaced femoral neck fractures have shown favorable short-term results for prosthetic replacement. The present report compares the results after a minimum of fifteen years. METHODS: From 1994 to 1998, 143 patients (146 hips) were randomized to closed reduction and internal fixation with two screws (n = 78) or a cemented total hip replacement (n = 68). The average age of the patients was eighty-four years (range, seventy-five to 101 years), and 38% were classified as mentally impaired. Failure after internal fixation was defined as early redisplacement, nonunion, symptomatic segmental collapse, or deep infection. In the arthroplasty group, failure was defined as two dislocations or more, implant loosening, deep infection, or a periprosthetic fracture. RESULTS: For the lucid patients, the failure rate was 55% after internal fixation compared with 5% after total hip replacement. For patients with mental impairment, it was 16% in both groups. CONCLUSIONS: Total hip replacement is superior to internal fixation in the treatment of a displaced femoral neck fracture.

Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study.

OBJECTIVE: To determine whether single-dose tranexamic acid given intravenously immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and blood transfusions. DESIGN: A randomized double-blind, placebo-controlled multicenter study. SETTING: Two university hospitals and two central hospitals in the southeast health region of Sweden. POPULATION: One hundred women with presumed advanced ovarian cancer scheduled for radical debulking surgery between March 2008 and May 2012 who complied with inclusion/exclusion criteria were randomized; 50 were allocated to receive tranexamic acid and 50 to receive placebo. Analysis was performed according to intention-to-treat principles. METHODS: The volume of tranexamic acid (15 mg/kg body weight, 100 mg/mL tranexamic acid) or the same volume of placebo (0.9% NaCl) was added to a 100-mL saline solution plastic bag. The study medication was given immediately before the start of surgery. Data were analyzed by means of non-parametric statistics and multivariate models adjusted for confounding factors. MAIN OUTCOME MEASURES: Blood loss and red blood cell transfusions. RESULTS: The total blood loss volume and transfusion rate were significantly lower in the tranexamic acid group compared with the placebo group. Median total blood loss was 520 and 730 mL, respectively (p = 0.03). Fifteen (30%) and 22 (44%), respectively received transfusions (odds ratio 0.44; upper 95% CI 0.97; p = 0.02). CONCLUSION: A single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates significantly in advanced ovarian cancer surgery. Tranexamic acid may be recommended as standard prophylactic treatment in advanced ovarian cancer surgery.

Teriparatide improves early callus formation in distal radial fractures.

BACKGROUND: Teriparatide (parathyreoid hormone; PTH 1-34) increases skeletal mass in humans and improves fracture healing in animals. A recent randomized multicenter trial of nonoperated distal radial fractures showed a moderate shortening of the time to restoration of cortical continuity by treatment with 20 microg (low-dose) teriparatide per day, but not with 40 microg (high-dose). As radiographic cortical continuity appears late in the healing process, perhaps too late for clinical relevance, we studied the qualitative appearance of the callus 5 weeks after fracture. METHODS: One third of the patients of the international trial were treated at Linköping University Hospital. The multicenter trial did not evaluate early callus formation. We therefore made a blinded qualitative scoring of the callus at 5 weeks in our 27 patients. Callus formation was arbitrarily classified as rich, intermediate, or poor. RESULTS: 9 patients were classified as rich (none had received placebo, 3 low-dose teriparatide, and 6 high-dose teriparatide). 9 patients were classified as intermediate (1 had received placebo, 5 low-dose, and 3 high-dose). 9 patients were classified as poor (7 had received placebo, 1 low-dose, and 1 high-dose) (p < 0.001). INTERPRETATION: This is a post hoc subgroup analysis of an outcome variable, which was not in the official protocol. The results must therefore be interpreted with caution. However, in combination with the results of the larger trial, the data suggest that radiographic quality at an early time point might be a sensitive variable, perhaps better than time to cortical continuity. Moreover, teriparatide appeared to improve early callus formation in distal radial fractures.

Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures.

Animal experiments show a dramatic improvement in skeletal repair by teriparatide. We tested the hypothesis that recombinant teriparatide, at the 20 microg dose normally used for osteoporosis treatment or higher, would accelerate fracture repair in humans. Postmenopausal women (45 to 85 years of age) who had sustained a dorsally angulated distal radial fracture in need of closed reduction but no surgery were randomly assigned to 8 weeks of once-daily injections of placebo (n = 34) or teriparatide 20 microg (n = 34) or teriparatide 40 microg (n = 34) within 10 days of fracture. Hypotheses were tested sequentially, beginning with the teriparatide 40 microg versus placebo comparison, using a gatekeeping strategy. The estimated median time from fracture to first radiographic evidence of complete cortical bridging in three of four cortices was 9.1, 7.4, and 8.8 weeks for placebo and teriparatide 20 microg and 40 microg, respectively (overall p = .015). There was no significant difference between the teriparatide 40 microg versus placebo groups (p = .523). In post hoc analyses, there was no significant difference between teriparatide 40 microg versus 20 microg (p = .053); however, the time to healing was shorter in teriparatide 20 microg than placebo (p = .006). The primary hypothesis that teriparatide 40 microg would shorten the time to cortical bridging was not supported. The shortened time to healing for teriparatide 20 microg compared with placebo still may suggest that fracture repair can be accelerated by teriparatide, but this result should be interpreted with caution and warrants further study.

Patients on the waiting list for total hip replacement: a 1-year follow-up study.

Untreated osteoarthritis (OA) in the hip causes pain and reduced physical and social functioning. The aim of this study was to evaluate the effect of waiting time on health-related quality of life (HRQOL), functional condition and dependence on help at the time of surgery and during follow-up 1 year after surgery. A further aim was to elucidate possible differences between men and women. Two hundred and twenty-nine consecutively included patients with OA in the hip were interviewed when assigned to the waiting list, again 1 week prior to surgery with unilateral total hip replacement (THR), and 1 year after surgery. Health-related quality of life and function were measured using the Nottingham Health Profile, EuroQoL and the Western Ontario and McMaster Universities Osteoarthritis Index. The result showed that the average waiting time was 239 days, that 15% of the patients were operated on within 3 months, and that 21% had to wait more than 6 months. At the time of surgery, HRQOL had deteriorated significantly (p < 0.05) and the number of patients receiving support from relatives had increased from 31% to 58% during the wait. At the 1-year follow-up, both HRQOL and functional condition had improved significantly despite the wait, and the need for support from relatives had decreased to 11% (p < 0.001). In conclusion, long waiting time for THR is detrimental to patients' HRQOL causing reduced functional condition, pain and increased need for support from relatives, which limit the independence in daily life.

A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery.

BACKGROUND: Hemospan (Sangart Inc., San Diego, CA), a polyethylene glycol-modified hemoglobin with unique oxygen transport properties, has successfully completed a phase I trial in healthy volunteers. Because adverse events are expected to increase with age, the authors conducted a phase II safety study of Hemospan in elderly patients undergoing elective hip arthroplasty during spinal anesthesia. METHODS: Ninety male and female patients, American Society of Anesthesiologists physical status I-III, aged 50-89 yr, in six Swedish academic hospitals were randomly assigned to receive either 250 or 500 ml Hemospan or Ringer's acetate (30 patients/group) before induction of spinal anesthesia. Safety assessment included vital signs and Holter monitoring from infusion to 24 h, evaluation of laboratory values, and fluid balance. The hypothesis to be tested was that the incidence of adverse events would be no more frequent in patients who received Hemospan compared with standard of care (Ringer's acetate). RESULTS: Three serious adverse events were noted, none of which was deemed related to study treatment. Liver enzymes, amylase, and lipase increased transiently in patients in all three groups. There were no significant differences in electrocardiogram or Holter parameters, but there was a suggestion of more bradycardic events in the treated groups. Hypotension was less frequent in the treated patients compared with controls. CONCLUSIONS: In comparison with Ringer's acetate, Hemospan mildly elevates hepatic enzymes and lipase and is associated with less hypotension and more bradycardic events. The absence of a high frequency of serious adverse events suggests that further clinical trials should be undertaken.

The total costs of a displaced femoral neck fracture: comparison of internal fixation and total hip replacement. A randomised study of 146 hips.

We randomised 143 patients--age 75 years or older--with displaced femoral neck fracture to either internal fixation or total hip replacement (THR) and compared the socio-economic consequences. In the internal fixation group, 34 of 78 hips underwent secondary surgery. In the THR group, 12 of 68 hips dislocated, the majority in mentally impaired patients. We calculated the total hospital costs for two years after operation. When secondary surgery was included, there was no difference in costs between the internal fixation and THR groups, or between the mentally impaired and lucid subgroups. The costs to the community were calculated comparing the baseline cost before surgery with the average cost per month during the first postoperative year. No difference was found between the treatment groups. The Harris hip scores were higher in the THR group, and pain was more common in the internal fixation group. In lucid patients, THR gives a better clinical result at the same cost.

Blood loss after total hip replacement: a prospective randomized study between wound compression and drainage.

A randomized, controlled study compared the effects of wound compression with drainage after primary total hip arthroplasty. In 51 patients, an inflatable cuff was placed over the wound underneath a girdle (System Calmed, Calmed AB, Askim, Sweden). Control patients had wound drainage (n = 54). Preoperative and intraoperative variables did not differ between groups. Total blood loss was calculated using hemoglobin balance; with compression it was 1510 +/- 656 mL (mean +/- SD) and in controls 1695 +/- 712 mL (P = .13). However, less blood was transfused in the compression group (P = .05). Wound infection was seen in 2 patients with compression and in 3 controls. Deep venous thrombosis occurred in 3 controls. Wound discharge was more frequent in controls (19/54 vs 8/51; P = .04). Thus, wound compression had no obvious negative effects and reduced wound discharge and need for transfusion. It may replace drainage after total hip arthroplasty.

Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients.

BACKGROUND: A blood transfusion is a costly transplantation of tissue that may endanger the health for the recipient. Blood transfusions are common after total hip arthroplasty. The total saving potential is substantial if the blood loss could be reduced. Studies on the use of tranexamic acid have shown interesting results, but its benefits in total hip arthroplasty have not yet been resolved. PATIENTS AND METHODS: 100 patients receiving a total hip arthroplasty (THA) got a single injection of tranexamic acid (15 mg/kg) or placebo intravenously before the start of the operation. The study was double-blind and randomized. Total blood loss was calculated from the hemoglobin (Hb) balance. Volume and Hb concentration of the drainage was measured 24 h after the operation. Intraoperative blood loss was estimated volumetrically and visually. RESULTS: The patients who received tranexamic acid (TA) bled less. The total blood loss was on average 0.97 L in the TA group and 1.3 L in the placebo group (p < 0.001). 8/47 (0.2) in the TA group were given blood transfusion versus 23/53 (0.4) in the placebo group (p = 0.009). Drainage volume and drainage Hb concentration were less in the TA group (p < 0.001 and p = 0.001). No thromboembolic complications occurred. INTERPRETATION: Considering the cost of blood and tranexamic acid only, use of the drug would save EUR 47 Euro per patient. We recommend a preoperative single dose of tranexamic acid for standard use in THA.