The ageing population and an increase in both the incidence and prevalence of cancer pose a healthcare challenge, some of which is borne by the orthopaedic community in the form of osteoporotic fractures and metastatic bone disease. In recent years there has been an increasing understanding of the pathways involved in bone metabolism relevant to osteoporosis and metastases in bone. Newer therapies may aid the management of these problems. One group of drugs, the antibody mediated anti-resorptive therapies (AMARTs) use antibodies to block bone resorption pathways. This review seeks to present a synopsis of the guidelines, pharmacology and potential pathophysiology of AMARTs and other new anti-resorptive drugs. . We evaluate the literature relating to AMARTs and new anti-resorptives with special attention on those approved for use in clinical practice. Denosumab, a monoclonal antibody against Receptor Activator for Nuclear Factor Kappa-B Ligand. It is the first AMART approved by the National Institute for Health and Clinical Excellence and the US Food and Drug Administration. Other novel anti-resorptives awaiting approval for clinical use include Odanacatib. Denosumab is indicated for the treatment of osteoporosis and prevention of the complications of bone metastases. Recent evidence suggests, however, that denosumab may have an adverse event profile similar to bisphosphonates, including atypical femoral fractures. It is, therefore, essential that orthopaedic surgeons are conversant with these medications and their safe usage. . Take home message: Denosumab has important orthopaedic indications and has been shown to significantly reduce patient morbidity in osteoporosis and metastatic bone disease. Cite this article: Bone Joint J 2016;98-B:160–5

Aims. Patients with osteoarthritis of the knee commonly have degenerative meniscal tears. Arthroscopic meniscectomy is frequently performed, although the benefits are debatable. Recent studies have concluded that there is no role for arthroscopic washout in osteoarthritis of the knee. Our aim was to perform a systematic review to assess the evidence for the efficacy of arthroscopic meniscectomy in patients with meniscal tears and degenerative changes in the knee. Patients and Methods. A literature search was performed, using the PubMed/MEDLINE database, for relevant articles published between 1975 and 2015. A total of six studies, including five randomised controlled trials and one cross-sectional study of a prospective cohort, met the inclusion criteria. Relevant information including study design, operations, the characteristics of the patients, outcomes, adverse events and further operations were extracted. Results. The degree of osteoarthritis in the patients who were included and the rate of cross over from one form of treatment to another varied in the studies. Two randomised controlled trials showed a benefit of arthroscopic surgery in patients with limited degenerative joint disease, compared with conservative treatment. One cross-sectional study showed that patients with less severe degenerative changes had better outcomes. Conclusion. Patients with symptomatic meniscal tears and degenerative changes in the knee can benefit from arthroscopic meniscectomy, particularly if the osteoarthritis is mild. A trial of conservative management may be effective and should be considered, especially in patients with moderate osteoarthritis. Cite this article: Bone Joint J 2016;98-B:934–8

Aims. The purpose of the present study was to evaluate the impact of intravenous tranexamic acid on the reduction of blood loss, transfusion rate, and early post-operative clinical outcome in total shoulder arthroplasty. Patients and Methods. A randomised, placebo-controlled trial which included 54 patients undergoing unilateral primary stemless anatomical or stemmed reverse total shoulder arthroplasty was undertaken. Patients received either 100 ml saline (placebo, n = 27), or 100 ml saline together with 1000 mg of tranexamic acid (TXA, n = 27) intravenously prior to skin incision and during wound closure. Peri-operative blood loss via an intra-articular drain was recorded and total blood loss was calculated. The post-operative transfusion rate was documented. Assessment of early clinical parameters included the visual analogue scale for pain (VAS), documentation of haematoma formation and adverse events. Results. Mean peri-operative blood drainage (placebo: 170 ml versus TXA: 50 ml, p = 0.001) and calculated mean total blood loss (placebo: 1248.2 ml versus TXA: 871.0 ml, p = 0.009) were significantly lower in the TXA group. No transfusions were necessary during the study period in either group. Mean VAS for pain significantly decreased from pre-operative (VAS 7) to the early post-operative period (VAS 1.7, p < 0.001). Significant differences regarding mean post-operative pain between placebo (VAS 2.0) and TXA (VAS 1.3) were detected (p = 0.05). The occurrence of haematomas was significantly more frequent in the placebo (59.3%, n = 16) than in the TXA group (25.9%, n = 6, p = 0.027). Whereas only mild haematomas developed in the TXA group, in the placebo group a total of 22.2% (n = 6) developed either moderate or severe haematomas. No adverse events associated with administration of TXA occurred. Conclusion. Intravenous administration of TXA successfully reduced mean peri-operative blood drainage, total estimated blood loss, pain during the first post-operative days, and haematoma formation in total shoulder arthroplasty. Cite this article: Bone Joint J 2017;99-B:1073–9

The aim of this study was to assess the effect of injecting genetically engineered chondrocytes expressing transforming growth factor beta 1 (TGF-β1) into the knees of patients with osteoarthritis. We assessed the resultant function, pain and quality of life. . A total of 54 patients (20 men, 34 women) who had a mean age of 58 years (50 to 66) were blinded and randomised (1:1) to receive a single injection of the active treatment or a placebo. We assessed post-treatment function, pain severity, physical function, quality of life and the incidence of treatment-associated adverse events. Patients were followed at four, 12 and 24 weeks after injection. At final follow-up the treatment group had a significantly greater improvement in the mean International Knee Documentation Committee score than the placebo group (16 points; -18 to 49, vs 8 points; -4 to 37, respectively; p = 0.03). The treatment group also had a significantly improved mean visual analogue score at final follow-up (-25; -85 to 34, vs -11 points; -51 to 25, respectively; p = 0.032). Both cohorts showed an improvement in Western Ontario and McMaster Osteoarthritis Index and Knee Injury and Osteoarthritis Outcome Scores, but these differences were not statistically significant. One patient had an anaphylactic reaction to the preservation medium, but recovered within 24 hours. All other adverse events were localised and resolved without further action. . This technique may result in improved clinical outcomes, with the aim of slowing the degenerative process, leading to improvements in pain and function. However, imaging and direct observational studies are needed to verify cartilage regeneration. Nevertheless, this study provided a sufficient basis to proceed to further clinical testing. Cite this article: Bone Joint J 2015;97-B:924–32

The aim of this study was to compare the operating time, length of stay (LOS), adverse events and rate of re-admission for elderly patients with a fracture of the hip treated using either general or spinal anaesthesia. Patients aged ≥ 70 years who underwent surgery for a fracture of the hip between 2010 and 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. Of the 9842 patients who met the inclusion criteria, 7253 (73.7%) were treated with general anaesthesia and 2589 (26.3%) with spinal anaesthesia. On propensity-adjusted multivariate analysis, general anaesthesia was associated with slightly increased operating time (+5 minutes, 95% confidence interval (CI) +4 to +6, p < 0.001) and post-operative time in the operating room (+5 minutes, 95% CI +2 to +8, p < 0.001) compared with spinal anaesthesia. General anaesthesia was associated with a shorter LOS (hazard ratio (HR) 1.28, 95% CI 1.22 to 1.34, p < 0.001). Any adverse event (odds ratio (OR) 1.21, 95% CI 1.10 to 1.32, p < 0.001), thromboembolic events (OR 1.90, 95% CI 1.24 to 2.89, p = 0.003), any minor adverse event (OR 1.19, 95% CI 1.09 to 1.32, p < 0.001), and blood transfusion (OR 1.34, 95% CI 1.22 to 1.49, p < 0.001) were associated with general anaesthesia. General anaesthesia was associated with decreased rates of urinary tract infection (OR 0.73, 95% CI 0.62 to 0.87, p < 0.001). There was no clear overall advantage of one type of anaesthesia over the other, and surgeons should be aware of the specific risks and benefits associated with each type. Cite this article: Bone Joint J 2015; 97-B:689–95

We hypothesised there was no clinical value in using an autologous blood transfusion (ABT) drain in either primary total hip (THR) or total knee replacement (TKR) in terms of limiting allogeneic blood transfusions when a modern restrictive blood management regime was followed. A total of 575 patients (65.2% men), with a mean age of 68.9 years (36 to 94) were randomised in this three-arm study to no drainage (group A), or to wound drainage with an ABT drain for either six hours (group B) or 24 hours (group C). The primary outcome was the number of patients receiving allogeneic blood transfusion. Secondary outcomes were post-operative haemoglobin (Hb) levels, length of hospital stay and adverse events. This study identified only 41 transfused patients, with no significant difference in distribution between the three groups (p = 0.857). The mean pre-operative haemoglobin (Hb) value in the transfused group was 12.8 g/dL (9.8 to 15.5) versus 14.3 g/dL (10.6 to 18.0) in the non-transfused group (p < 0.001, 95% confidence interval: 1.08 to 1.86). Post-operatively, the median of re-transfused shed blood in patients with a THR was 280 mL (Interquartile range (IQR) 150 to 400) and in TKR patients 500 mL (IQR 350 to 650) (p <  0.001). ABT drains had no effect on the proportion of transfused patients in primary THR and TKR. The secondary outcomes were also comparable between groups. Cite this article: Bone Joint J 2014;96-B:765–71

Aims. The best marker for assessing glycaemic control prior to total knee arthroplasty (TKA) remains unknown. The purpose of this study was to assess the utility of fructosamine compared with glycated haemoglobin (HbA1c) in predicting early complications following TKA, and to determine the threshold above which the risk of complications increased markedly. Patients and Methods. This prospective multi-institutional study evaluated primary TKA patients from four academic institutions. Patients (both diabetics and non-diabetics) were assessed using fructosamine and HbA1c levels within 30 days of surgery. Complications were assessed for 12 weeks from surgery and included prosthetic joint infection (PJI), wound complication, re-admission, re-operation, and death. The Youden’s index was used to determine the cut-off for fructosamine and HbA1c associated with complications. Two additional cut-offs for HbA1c were examined: 7% and 7.5% and compared with fructosamine as a predictor for complications. Results. Overall, 1119 patients (441 men, 678 women) were included in the study. Fructosamine level of 293 µmol/l was identified as the optimal cut-off associated with complications. Patients with high fructosamine (> 293 µmol/l) were 11.2 times more likely to develop PJI compared with patients with low fructosamine (p = 0.001). Re-admission and re-operation rates were 4.2 and 4.5 times higher in patients with fructosamine above the threshold (p = 0.005 and p = 0.019, respectively). One patient (1.7%) from the elevated fructosamine group died compared with one patient (0.1%) in the normal fructosamine group (p = 0.10). These complications remained statistically significant in multiple regression analysis. Unlike fructosamine, all three cut-offs for HbA1c failed to show a significant association with complications. Conclusion. Fructosamine is a valid and an excellent predictor of complications following TKA. It better reflects the glycaemic control, has greater predictive power for adverse events, and responds quicker to treatment compared with HbA1c. These findings support the screening of all patients undergoing TKA using fructosamine and in those with a level above 293 µmol/l, the risk of surgery should be carefully weighed against its benefit. Cite this article: Bone Joint J 2019;101-B(7 Supple C):3–9

We carried out a prospective, continuous study on 529 patients who underwent primary total knee replacement between January 2006 and December 2007 at a major teaching hospital. The aim was to investigate weight change and the functional and clinical outcome in non-obese and obese groups at 12 months post-operatively. The patients were grouped according to their pre-operative body mass index (BMI) as follows: non-obese (BMI < 30 kg/m. 2. ), obese (BMI . 3. 30 to 39 kg/m. 2. ) and morbidly obese (BMI > 40 kg/m. 2. ). The clinical outcome data were available for all patients and functional outcome data for 521 (98.5%). Overall, 318 (60.1%) of the patients were obese or morbidly obese. At 12 months, a clinically significant weight loss of ≥ 5% had occurred in 40 (12.6%) of the obese patients, but 107 (21%) gained weight. The change in the International Knee Society score was less in obese and morbidly obese compared with non-obese patients (p = 0.016). Adverse events occurred in 30 (14.2%) of the non-obese, 59 (22.6%) of the obese and 20 (35.1%) of the morbidly obese patients (p = 0.001)

Aims. The aim of this study was to examine the efficacy and safety of multiple boluses of intravenous (IV) tranexamic acid (TXA) on the hidden blood loss (HBL) and inflammatory response following primary total hip arthroplasty (THA). Patients and Methods. A total of 150 patients were allocated randomly to receive a single bolus of 20 mg/kg IV TXA before the incision (group A), a single bolus followed by a second bolus of 1 g IV-TXA three hours later (group B) or a single bolus followed by two boluses of 1 g IV-TXA three and six hours later (group C). All patients were treated using a standard peri-operative enhanced recovery protocol. Primary outcomes were HBL and the level of haemoglobin (Hb) as well as the levels of C-reactive protein (CRP) and interleukin-6 (IL-6) as markers of inflammation. Secondary outcomes included the length of stay in hospital and the incidence of venous thromboembolism (VTE). Results. The mean HBL was significantly lower in group C (402.13 ml standard deviation (. sd). 225.97) than group A (679.28 ml. sd. 277.16, p < 0.001) or B (560.62 ml . sd. 295.22, p = 0.010). The decrease in the level of Hb between the pre-operative baseline and the level on the third post-operative day was 30.82 g/L (. sd. 6.31 g/L) in group A, 27.16 g/L (. sd. 6.83) in group B and 21.98 g/L (. sd. 3.72) in group C. This decrease differed significantly among the three groups (p < 0.01). The mean level of CRP was significantly lower in group C than in the other two groups on the second (p ≤ 0.034) and third post-operative days (p ≤ 0.014). The levels of IL-6 were significantly lower in group C than group A on the first three post-operative days (p = 0.023). The mean length of stay was significantly lower in group C than group A (p = 0.023). No VTE or other adverse events occurred. Conclusion. Multiple boluses of IV-TXA can effectively reduce HBL following primary THA. A regime of three boluses leads to a smaller decrease in the level of Hb, less post-operative inflammation and a shorter length of stay in hospital than a single bolus. Cite this article: Bone Joint J 2017;99-B:1442–9

Autologous retransfusion and no-drainage are both blood-saving measures in total hip replacement (THR). A new combined intra- and post-operative autotransfusion filter system has been developed especially for primary THR, and we conducted a randomised controlled blinded study comparing this with no-drainage. A total of 204 THR patients were randomised to autologous blood transfusion (ABT) (n = 102) or no-drainage (n = 102). In the ABT group, a mean of 488 ml (. sd. 252) of blood was retransfused. The mean lowest post-operative haemoglobin level during the hospital stay was higher in the autotransfusion group (10.6 g/dl (7.8 to 13.9) vs 10.2 g/dl (7.5 to 13.3); p = 0.01). The mean haemoglobin levels for the ABT and no-drainage groups were not significantly different on the first day (11.3 g/dl (7.8 to 13.9) vs 11.0 g/dl (8.1 to 13.4); p = 0.07), the second day (11.1 g/dl (8.2 to 13.8) vs 10.8 g/dl (7.5 to 13.3); p = 0.09) or the third day (10.8 g/dl (8.0 to 13.0) vs 10.6 g/dl (7.5 to 14.1); p = 0.15). The mean total peri-operative net blood loss was 1464 ml (. sd. 505) in the ABT group and 1654 ml (. sd. 553) in the no-drainage group (p = 0.01). Homologous blood transfusions were needed in four patients (3.9%) in the ABT group and nine (8.8%) in the no-drainage group (p = 0.15). No statistically significant difference in adverse events was found between the groups. The use of a new intra- and post-operative autologous blood transfusion filter system results in less total blood loss and a smaller maximum decrease in haemoglobin levels than no-drainage following primary THR. Cite this article: Bone Joint J 2013;95-B:616–22

Aims. The aim of this study was to identify the most effective regimen of multiple doses of oral tranexamic acid (TXA) in achieving maximum reduction of blood loss in total knee arthroplasty (TKA). Patients and Methods. In this randomized controlled trial, 200 patients were randomized to receive a single dose of 2.0 g of TXA orally two hours preoperatively (group A), a single dose of TXA followed by 1.0 g orally three hours postoperatively (group B), a single dose of TXA followed by 1.0 g three and nine hours postoperatively (group C), or a single dose of TXA followed by 1.0 g orally three, nine, and 15 hours postoperatively (group D). All patients followed a routine enhanced-recovery protocol. The primary outcome measure was the total blood loss. Secondary outcome measures were hidden blood loss (HBL), reduction in the level of haemoglobin, the rate of transfusion and adverse events. Results. Groups C (661.1 ml, . sd. 262.4) and D (597.7 ml, . sd. 219.6) had significantly lower mean total blood loss compared with groups A and B. The mean HBL was significantly lower in groups B (699.2 ml), C (533.1 ml) and D (469.9 ml) than in group A (p = 0.006, p < 0.001, and p < 0.001, respectively). Groups C (2.22 ml, . sd. 0.91) and D (2.04 ml, . sd. 0.95) had a lower reduction in the level of haemoglobin than groups A and B. However, there were no differences between groups C and D in relation to the three parameters. Conclusion. The addition of two or three postoperative doses of TXA to one preoperative dose produced a significant reduction in blood loss. The two-dose postoperative regimen is the least necessary regimen for clinical efficacy in primary unilateral TKA. The three-dose regimen produced maximum reduction of blood loss. Cite this article: Bone Joint J 2018;100-B:1025–32

Objective . A clinical investigation into a new bone void filler is giving first data on systemic and local exposure to the anti-infective substance after implantation. Method . A total of 20 patients with post-traumatic/post-operative bone infections were enrolled in this open-label, prospective study. After radical surgical debridement, the bone cavity was filled with this material. The 21-day hospitalisation phase included determination of gentamicin concentrations in plasma, urine and wound exudate, assessment of wound healing, infection parameters, implant resorption, laboratory parameters, and adverse event monitoring. The follow-up period was six months. . Results . Systemic exposure to gentamicin after implantation was very low as local gentamicin concentrations were measured in wound exudate after six to ten hours. There were no signs of infectious complication throughout the clinical phase. Four patients had recurrent infections several weeks to months after implantation. The outcome was deemed successful by remission of infection in 16 (80%) of these problematic long-term treated patients. Safety laboratory measurements did not indicate nephrotoxic or hepatotoxic effects. . Conclusions . Local application of calcium sulphate/carbonate bone void filler comprising gentamicin revealed sufficient active local levels of the antibiotic by simultaneous significant low systemic exposure in patients with mostly chronic osteomyelitis/osteitis. The material was safe and well tolerated. Cite this article: Bone Joint Res 2014;3:223–9

Aims. Few studies have examined the long-term outcome of carpal tunnel release (CTR). The aim of this study was to evaluate the patient-reported long-term outcome of CTR for electrophysiologically severe carpal tunnel syndrome (CTS). Patients and Methods. We reviewed the long-term outcome of 40 patients with bilateral severe CTS who underwent 80 CTRs (46 open, 34 endoscopic) between 2002 and 2012. The outcomes studied were patient-reported outcomes of numbness resolution, the Boston Carpal Tunnel Questionnaire (BCTQ) score, and patient satisfaction. Results. The mean follow-up was 9.3 years. Complete resolution of numbness was reported by 93.8% of patients, persistent numbness by 3.8%, and recurrent numbness by 2.5%. The mean BCTQ symptom score was 1.1 (. sd. 0.3; 1.0 to 2.55) and the mean Boston function score was 1.15 (. sd. 0.46; 1.0 to 3.5). 72.5% of patients were asymptomatic and had no functional impairment. Men had poorer outcomes than women and patients < 55 years had poorer outcomes than patients ≥ 55 years. All patients who had undergone endoscopic CTR reported complete resolution of numbness compared with 89.1% of those who had undergone open release (p = 0.047). There was no significant difference in outcome between dominant and non-dominant hands. Patient satisfaction rates were good. There were no adverse events. Conclusion. CTR has a favourable outcome and good rates of satisfaction, even in patients with bilateral severe CTS at a mean of nine years after surgery. Endoscopic CTR has a higher rate of numbness resolution than open surgery. There were no significant differences in outcome between the dominant and non-dominant hand. Cite this article: Bone Joint J 2017;99-B:1348–53

Breast cancer is generally managed surgically with adjuvant agents which include hormone therapy, chemotherapy, radiotherapy and bisphosphonate therapy. However, some of these adjuvant therapies may cause adverse events, including wound infection, neutropenia, bone marrow suppression and fever. The simultaneous presentation of osteonecrosis and osteomyelitis has not previously been described in patients with breast cancer undergoing hormone therapy and chemotherapy. We report a patient with breast cancer who developed bone infarcts in both legs as well as osteomyelitis in the right distal tibia after treatment which included a modified radical mastectomy, hormone therapy and chemotherapy. Simultaneous osteonecrosis and osteomyelitis should be considered in patients with breast cancer who are receiving chemotherapy and hormone therapy who present with severe bone pain, especially if there have been infective episodes during treatment

There is currently limited information available on the benefits and risks of extended thromboprophylaxis after hip fracture surgery. SAVE-HIP3 was a randomised, double-blind study conducted to evaluate the efficacy and safety of extended thromboprophylaxis with the ultra-low molecular-weight heparin semuloparin compared with placebo in patients undergoing hip fracture surgery. After a seven- to ten-day open-label run-in phase with semuloparin (20 mg once daily subcutaneously, initiated post-operatively), patients were randomised to once-daily semuloparin (20 mg subcutaneously) or placebo for 19 to 23 additional days. The primary efficacy endpoint was a composite of any venous thromboembolism (VTE; any deep-vein thrombosis and non-fatal pulmonary embolism) or all-cause death until day 24 of the double-blind period. Safety parameters included major and clinically relevant non-major bleeding, laboratory data, and treatment-emergent adverse events (TEAEs). Extended thromboprophylaxis with semuloparin demonstrated a relative risk reduction of 79% in the rate of any VTE or all-cause death compared with placebo (3.9% vs 18.6%, respectively; odds ratio 0.18 (95% confidence interval 0.07 to 0.45), p < 0.001). Two patients in the semuloparin group and none in the placebo group experienced clinically relevant bleeding. TEAE rates were similar in both groups. In conclusion, the SAVE-HIP3 study results demonstrate that patients undergoing hip fracture surgery benefit from extended thromboprophylaxis. Cite this article: Bone Joint J 2013;95-B:459–66

Total knee arthroplasty (TKA) is a major orthopaedic intervention. The length of a patient's stay has been progressively reduced with the introduction of enhanced recovery protocols: day-case surgery has become the ultimate challenge. This narrative review shows the potential limitations of day-case TKA. These constraints may be social, linked to patient’s comorbidities, or due to surgery-related adverse events (e.g. pain, post-operative nausea and vomiting, etc.). . Using patient stratification, tailored surgical techniques and multimodal opioid-sparing analgesia, day-case TKA might be achievable in a limited group of patients. The younger, male patient without comorbidities and with an excellent social network around him might be a candidate. Demographic changes, effective recovery programmes and less invasive surgical techniques such as unicondylar knee arthroplasty, may increase the size of the group of potential day-case patients. . The cost reduction achieved by day-case TKA needs to be balanced against any increase in morbidity and mortality and the cost of advanced follow-up at a distance with new technology. These factors need to be evaluated before adopting this ultimate ‘fast-track’ approach. . Cite this article: Bone Joint J 2015;97-B(10 Suppl A):40–4

Aims

During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon’s decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing.

Aims

To map literature on prognostic factors related to outcomes of revision total knee arthroplasty (rTKA), to identify extensively studied factors and to guide future research into what domains need further exploration.

Aims

The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component.

Pain, swelling and inflammation are expected during the recovery from total knee arthroplasty (TKA) surgery. The severity of these factors and how a patient copes with them may determine the ultimate outcome of a TKA. Cryotherapy and compression are frequently used modalities to mitigate these commonly experienced sequelae. However, their effect on range of motion, functional testing, and narcotic consumption has not been well-studied. A prospective, multi-center, randomised trial was conducted to evaluate the effect of a cryopneumatic device on post-operative TKA recovery. Patients were randomised to treatment with a cryopneumatic device or ice with static compression. A total of 280 patients were enrolled at 11 international sites. Both treatments were initiated within three hours post-operation and used at least four times per day for two weeks. The cryopneumatic device was titrated for cooling and pressure by the patient to their comfort level. Patients were evaluated by physical therapists blinded to the treatment arm. Range of motion (ROM), knee girth, six minute walk test (6MWT) and timed up and go test (TUG) were measured pre-operatively, two- and six-weeks post-operatively. A visual analog pain score and narcotic consumption was also measured post-operatively. At two weeks post-operatively, both the treatment and control groups had diminished ROM and function compared to pre-operatively. Both groups had increased knee girth compared to pre- operatively. There was no significant difference in ROM, 6MWT, TUG, or knee girth between the 2 groups. We did find a significantly lower amount of narcotic consumption (509 mg morphine equivalents) in the treatment group compared with the control group (680 mg morphine equivalents) at up to two weeks postop, when the cryopneumatic device was being used (p < 0.05). Between two and six weeks, there was no difference in the total amount of narcotics consumed between the two groups. At six weeks, there was a trend toward a greater distance walked in the 6MWT in the treatment group (29.4 meters versus 7.9 meters, p = 0.13). There was a significant difference in the satisfaction scores of patients with their cooling regimen, with greater satisfaction in the treatment group (p < 0.0001). There was no difference in ROM, TUG, VAS, or knee girth at six weeks. There was no difference in adverse events or compliance between the two groups. A cryopneumatic device used after TKA appeared to decrease the need for narcotic medication from hospital discharge to 2 weeks post-operatively. There was also a trend toward a greater distance walked in the 6MWT. Patient satisfaction with the cryopneumatic cooling regimen was significantly higher than with the control treatment.