Aims. The aims of this study were to evaluate the incidence of postoperatively restricted weight-bearing and its association with outcome in patients who undergo surgery for a fracture of the hip. Patients and Methods. Patient aged > 60 years undergoing surgery for a hip fracture were identified in the 2016 National Surgical Quality Improvement Program (NSQIP) Hip Fracture Targeted Procedure Dataset. Analysis of the effect of restricted weight-bearing on adverse events, delirium, infection, transfusion, length of stay, return to the operating theatre, readmission and mortality within 30 days postoperatively were assessed. Multivariate regression analysis was used to adjust for confounding demographic, comorbid and procedural characteristics. Results. Of the 4918 patients who met inclusion criteria, 3668 (63.53%) were allowed to weight-bear as tolerated postoperatively. Controlling for patient and procedural factors, multivariate odds of any adverse event, major adverse event, delirium, infection, transfusion, length of stay ≥ 75th percentile (six days) and mortality within 30 days were all higher in patients with weight-bearing restrictions. Notably, there were no differences for thromboembolic events, return to the operating theatre or readmission within 30 days between the groups. Conclusion. Elderly patients with a fracture of the hip with postoperative weight-bearing restrictions have a significantly greater risk of developing most adverse events compared with those who are encouraged to weight-bear as tolerated. These findings emphasize the importance of immediate weight-bearing as tolerated to optimize the outcome in these frail patients; however nearly 25% of surgeons fail to meet this evidence-based guideline. Cite this article: Bone Joint J 2018;100-B:1377–84

Implementation of the World Health Organisation checklists have reduced errors, however, the impact of pre-operative briefings on adverse events has not been assessed. A prospective case control study assessing the association between pre-operative briefings and minor, potentially major and major adverse events was performed in two phases. Phase one involved prospective data collection for trauma and orthopaedic lists over 2 weeks. Changes were implemented and following this, the study was repeated (phase two). 41 lists were audited during phase one and 47 lists in phase two. Adequate pre-operative briefings were performed in 10/41 lists (24%) in phase one. There was a significant association between the occurrences of intra-operative adverse events (n=37) when a briefing was not performed (p=<0.01), and when a briefing was performed incompletely (p=0.01). In phase two, after staff re-education and policy change, briefings were found to be adequate in 38/47 lists (81%) with the occurrence of only three minor adverse events. Team familiarity also improved significantly (p=0.02). Inadequate pre-operative briefings are associated with increased minor adverse events and are detrimental to team familiarity. On the basis of our findings we recommend that all surgical units perform pre-operative briefings

One potential approach to addressing the current hip and knee arthroplasty backlog is via adoption of surgical prioritisation methods, such as use of pre-operative health related quality of life (HRQOL) assessment. We set out to determine whether dichotomization using a previously identified bimodal EuroQol Five-Dimension (EQ-5D) distribution could be used to triage waiting lists. 516 patients had data collected regarding demographics, perioperative variables and patient reported outcome measures (pre-operative & 1-year post-operative EQ-5D-3L and Oxford Hip and Knee Scores (OHS/OKS). Patients were split into two equal groups based on pre-operative EQ-5D Time Trade-Off (TTO) scores and compared (Group1 [worse HRQOL] = −0.239 to 0.487; Group2 [better HRQOL] = 0.516 to 1 (best)). The EQ5D TTO is a widely used and validated HRQOL measure that generates single values for different combinations of health-states based upon how individuals compare x years of healthy living to x years of illness. We identified that those in Group1 had significantly greater improvement in post-operative EQ-5D TTO scores compared to Group2 (Median 0.67vs.0.19; p<0.0001 respectively), as well as greater improvement in OHS/OKS (Mean 22.4vs16.4; p<0.0001 respectively). Those in Group2 were significantly less likely to achieve EQ-5D MCID attainment (OR 0.13, 95%CI 0.07–0.23; p<0.0001) with a trend towards lower OHS/OKS MCID attainment (OR 0.66, 95%CI 0.37–1.19; p=0.168). There was no statistically significant difference in adverse events. These finding suggest that a pre-operative EQ-5D cut-off of ≤0.487 for hip and knee arthroplasty prioritisation may help to maximise clinical utility and cost-effectiveness in a limited resource setting post COVID-19

Aims. Distal radial fractures are the most common fracture sustained by the adult population. Most can be treated using cast immobilization without the need for surgery. The aim of this study was to assess the feasibility of a definitive trial comparing the commonly used fibreglass cast immobilization with an alternative product called Woodcast. Woodcast is a biodegradable casting material with theoretical benefits in terms of patient comfort as well as benefits to the environment. Methods. This was a multicentre, two-arm, open-label, parallel-group randomized controlled feasibility trial. Patients with a fracture of the distal radius aged 16 years and over were recruited from four centres in the UK and randomized (1:1) to receive a Woodcast or fibreglass cast. Data were collected on participant recruitment and retention, clinical efficacy, safety, and patient acceptability. Results. Over an eight-month period, 883 patients were screened, 271 were found to be eligible, and 120 were randomized. Patient-reported outcome measures were available for 116 (97%) of participants at five weeks and 99 (83%) at three months. Clinical outcomes and patient acceptability were similar between the two interventions and no serious adverse events were reported in either intervention arm. Conclusion. Both interventions were deemed efficacious and safe in the cohort studied. This study showed that a definitive study comparing Woodcast and fibreglass was feasible in terms of patient recruitment and retention. Cite this article: Bone Joint J 2020;102-B(1):48–54

Over the last decade stemless shoulder arthroplasty has become increasingly popular. However, stability of metaphyseal loading humeral components remains a concern. This study aimed to assess the stability of the Affinis stemless humeral component using Radiostereometric analysis (RSA). Patients underwent total shoulder arthroplasty via a standardised technique with a press-fit stemless humeral component and a cemented pegged glenoid. Tantalum beads were inserted into the humerus at the time of operation. RSA of the relaxed shoulder was completed at weeks 1, 6, 13, 26, 52 and 104 post-operatively. Stressed RSA with 12 newtons of abduction force was completed from week 13 onwards. ABRSA 5.0 software (Downing Imaging Limited, Aberdeen) was used to calculate humeral component migration and induced movement. 15 patients were recruited. Precision was: 0.041, 0.034, 0.086 and 0.101 mm for Superior, Medial, Posterior and Total Point Motion (TPM) respectively. The mean TPM over 2 years was 0.24 (0.30) mm, (Mean (Standard deviation)). The mean rate of migration per 3 month time period decreased from 0.45 (0.31) to 0.02 (0.01) mm over 2 years. Mean inducible movement TPM peaked at 26 weeks at 0.1 (0.08) mm, which reduced to 0.07 (0.06) mm by 104 weeks when only 3 patients had measurable inducible motion. There was no clear trend in direction of induced movement. There were no adverse events or revisions required. We conclude migration of the humeral component was low with little inducible movement in the majority of patients implying initial and 2 year stability of the stemless humeral component

Aims. The aims of this study were to characterize the frequency of missing data in the National Surgical Quality Improvement Program (NSQIP) database and to determine how missing data can influence the results of studies dealing with elderly patients with a fracture of the hip. Patients and Methods. Patients who underwent surgery for a fracture of the hip between 2005 and 2013 were identified from the NSQIP database and the percentage of missing data was noted for demographics, comorbidities and laboratory values. These variables were tested for association with ‘any adverse event’ using multivariate regressions based on common ways of handling missing data. Results. A total of 26 066 patients were identified. The rate of missing data was up to 77.9% for many variables. Multivariate regressions comparing three methods of handling missing data found different risk factors for postoperative adverse events. Only seven of 35 identified risk factors (20%) were common to all three analyses. Conclusion. Missing data is an important issue in national database studies that researchers must consider when evaluating such investigations. Cite this article: Bone Joint J 2018;100-B:226–32

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

Introduction. Ilizarov fixator is an invaluable tool in managing complex orthopaedic problem. Many factors influence adverse events such as pin site infections and failure of treatment. Our study evaluated risk factors affecting patient compliance and unfavourable outcome of Ilizarov surgery. Materials and Methods. This is a retrospective observational study conducted at LNH, Karachi over a period of 4 years. Factors affecting patient compliance towards frame care such as family income, living standard, ethnic/cultural background etc were evaluated. Outcome measures were evaluated as a result of poor frame care. T-Test was used for continuous and chi-square were used for categorical variables. Individual risk factors were evaluated using logistic regression model. Results. Total 193 patients were evaluated, among them 37 (19.17%) had unfavourable outcome i.e, pin tract infections in 28(14%) and failure of treatment in 9(4.6%). Failure of treatment was noted in 4 patients who abandon treatment while amputation was done in rest of 5 patients due to fulminant infection in 2, RSD in 2 and vascular compromise in 1 patient. It was observed that ethnic background, education and patient's own interest in frame care played a significant role for pin tract infections and failure of treatment. Conclusion. Patient compliance with frame care in Ilizarov surgery significantly affecting outcomes that needs patient counselling in order to get optimal results from treatment

Introduction. Distal tibial fractures are notoriously difficult to treat and a lack of consensus remains on the best approach. This study examined clinical and functional outcomes in such patients treated definitively by circular external fixation (Ilizarov). Patients and Methods: Between July 2011 and May 2016, patients with fractures extending to within 1 muller square of the ankle were identified from our prospective Ilizarov database. Existing data was supplemented by review of clinical records. Fractures were classified according to the AO/OTA classification. Functional outcome data, including general measures of health related quality of life (SF-12 and Euroqol) and limb specific scores (Olerud and Molander Score and Lysholm scores) had been routinely collected for part of the study period. Patients in whom this had not been collected were asked to complete these by post. Adverse events were documented according to Paley's classification of: problems, obstacles and complications. Results. 142 patients with 143 fractures were identified, 40 (28%) were open, 94 (66%) were intra-articular, 85 (59%) were tertiary referrals. 32% were type 1, 28%, type 2 and 40% type 3 AO/OTA severity. 139 (97%) of the fractures united (2 non-unions, 1 amputation and 2 delayed unions who remain in frames), at a median of 165 days (range 104 to 429, IQR 136 to 201). 62% united by 6 months, 87% by 9 months and 94% by 1 year. Both non-unions have united with further treatment. Closed fractures united more rapidly than open (median 157 vs 185 days; p=0.003) and true Pilon (43C3) fractures took longer to unite other fractures (median 156 vs 190 days; p<0.001). 34% of patients encountered a problem, 12% an obstacle and 10% a complication. Of the complications, 6 (4%) were minor, 5 (3.5%) major not interfering with the goals of treatment and 4 (3%) major interfering with treatment goals (including the 2 patients with non-union and 1 who underwent amputation as well as 1 significant mal-union). This will increase to 4% if the 2 delayed unions fail to unite. Overall 56% reported good or excellent ankle scores at last report, 28% fair and 16% poor. Closed, extra-articular and non-43C3 fractures had better functional outcome scores than open, intra-articular and 43C3 fractures respectively. Conclusions. This study demonstrates a high union and low serious complication rate, suggesting that external ring fixation is a safe and effective treatment for these injuries. *Judged best paper*

Aims

To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment.

Introduction. Viscosupplementation is used widely to provide symptomatic relief to patients with knee OA. This study aimed to compare the efficacy and safety of the standard (3×2ml) and single (1×6ml) dosing regimens of hylan G-F 20. Methods. Prospective, randomized, blinded (reviewers), comparative independent study. Inclusion criteria was OA knee pain e 60mm on a 100mm VAS; no prior intra articular (IA) injection. Patients were randomised to recieve 1 × 6mL or 3 × 2mL hylan G-F 20. Follow-up at 1, 6, 12, 26 and 52 weeks. Analgesics prohibited for 24 hours prior to follow-up assessments and NSAID_s for 26 wks. All adverse events (AE) were recorded. Primary outcome measure: Target knee pain (VAS) at 26 weeks. Secondary outcome measures included WOMAC, Oxford knee score, SF12. Results. 412 patients were randomized (1 × 6mL N=194, 3 × 2 mL N=218). There were no significant differences in age, gender or grade of OA. Injection and/or treatment-related AE (all mild/moderate) were reported in 10.5% (3 × 2 mL) and 9.1% (1 × 6 mL) of patients Significant pain reduction was observed in both groups at 26 weeks (3 × 2 mL: 50% (mean) decrease, 1 × 6mL: 45%). There were no significant differences between groups for any of the primary or secondary outcome measures at 26 weeks. Discussion and Conclusion. Single dose of 6 mL hylan G-F 20 offer comparable safety and efficacy to 3 × 2 mL at 26 weeks. It provides both the patients and physicians a choice with the potential additional benefits of reduced operational costs

Background. Hip resurfacing arthroplasty (HRA) has seen a recent revival with third generation Metal-on-Metal prostheses and is now widely in use. However, safety and effectiveness of hip resurfacing are still questioned. We systematically reviewed peer-reviewed literature on hip resurfacing arthroplasty to address these issues. Objective. To evaluate implant survival and functional outcomes of hybrid Metal-on-Metal hip resurfacing arthroplasty (HRA). Method. Electronic databases and reference lists were searched from 1988 to May 2010. Identified abstracts were checked for inclusion or exclusion by two independent reviewers. Data were extracted and summarized by one reviewer and verified by a second reviewer. Main study endpoint was implant survival, which we compared with the National Institute of Clinical Excellence (NICE) benchmark. We also evaluated radiological and functional outcomes, failure modes and other adverse events. The quality of evidence was judged using the Grading of Recommendations Assessment, Development and Evaluation system (GRADE). Results. We identified 539 articles, of which 29 met the inclusion criteria. The studies included one randomised clinical trial, 27 prospective case series and one retrospective case series. Data were extracted from these 29 articles, totalling 10621 resurfaced hips, providing details on five out of 11 resurfacing devices on the market. Mean follow up ranged from 0.6 to 10.5 years and implant survival ranged from 84% to 100%. Of the 10621 hips, 370 were revised (3.5%), with aseptic loosening as most frequent failure mode. None of the HRA implants used to date met the full 10 year NICE benchmark. Thirteen studies showed satisfactory implant survival percentages compared to the three year NICE entry-benchmark. These 13 studies used the BHR implant (eight studies), the Conserve plus (two studies), the Durom implant (one study), the Cormet 2000 implant (one study) or both the McMinn and the BHR implant (one study)

Introduction. In Europe, injectable collagenase clostridium histolyticum (CCH) is a novel, minimally invasive, non-surgical therapy with efficacy in correcting Dupuytren's contracture (DC). We evaluated the efficacy and tolerability of 5 CCH injections using a protocol designed to follow clinical practice. Methods. This was a 20-center, 9-month, open-label study in which DC patients with primary flexion deformities 20° (100° for MP; 80° for PIP) received 3 CCH (0.58 mg) injections/joint (5 injections/patient) at 30-day intervals. The primary endpoint was clinical success, defined as a reduction in contracture to 5° 30 days after the last injection (“Day 30”). After first injection into a prioritized joint, patients opted to receive up to 2 more injections into the same cord or cords from other affected joints whether or not they achieved clinical success with the first joint. Adverse events (AEs) were monitored. Results. For the primary endpoint, 71% of MP (n=343) and 41% of PIP (n=244) joints showed a reduction in contracture to 5° with CCH injections. Of joints that did not achieve clinical success, 66% of MP (n=100) and 38% of PIP joints (n=144) showed 50% reduction in contracture after CCH. For range of motion (ROM), mean±SD increase from baseline to Day 30 was 33.0±16.2° for MP and 27.5±18.5° for PIP joints. Most commonly reported AEs were localized edema, bruising, pain, swelling, and tenderness; most resolved without intervention. Two serious AEs, deep vein thrombosis in the leg and tendonitis with partial tendon/ligament injury, were deemed possibly and probably related to treatment, respectively. Conclusions. Results from this open-label study, designed to follow clinical practice, provide support for the efficacy of CCH in correcting the flexion deformity of MP/PIP joints caused by DC. Clinical success and ROM improvements were comparable to those observed in randomized, placebo-controlled trials. This study was funded by Auxilium Pharmaceuticals, Inc

Aims

Pneumatic tourniquets are often used during the surgical treatment of unstable traumatic ankle fractures. The aim of this study was to assess the risk of reoperation after open reduction and internal fixation of ankle fractures with and without the use of pneumatic tourniquets.

Aims

Occult (clinical) injuries represent 15% of all scaphoid fractures, posing significant challenges to the clinician. MRI has been suggested as the gold standard for diagnosis, but remains expensive, time-consuming, and is in high demand. Conventional management with immobilization and serial radiography typically results in multiple follow-up attendances to clinic, radiation exposure, and delays return to work. Suboptimal management can result in significant disability and, frequently, litigation.

Aims

The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial.

Background. Radiofrequency Kyphoplasty (RFK) provides a new minimally invasive procedure to treat vertebral compression fractures (VCF). Purpose. The purpose of this study was to investigate the functional outcomes, safety and radiographic outcomes after the treatment of painful osteolytic vertebral fractures treated with a novel minimally invasive procedure, RFK. Material and Methods. 88 patients (50 females and 38 males) with 158 osteolytic vertebral fractures were treated with RFK using the StabiliT Vertebral Augmentation System (Dfine Inc, San Jose, CA). The StabiliT System provides a navigational osteotome to create a site and size specific cavity prior to delivering ultrahigh viscosity cement with an extended working time (done by applying radiofrequency energy to the cement immediately prior to entering the patient). 12 months follow up in 60 patients (36 females and 24 males) with 110 treated vertebrae are reported. Pre- and postoperative, 3, 6 and 12 months clinical parameters (Visual Analogue Scale, Oswestry Disability Index score), and radiological parameters (vertebral height and kyphotic angle) were measured. Results. The median pain scores (VAS) (p<0.001) and the Oswestry Disability Score (p<0.001) improved significantly from pre- to post-treatment and maintained at 3, 6 and 12 months follow up. Postoperative, 3,6 and 12 months follow-up RFK restored and stabilized the vertebral height and avoided further kyphotic deformity. No symptomatic cement leaks or serious adverse events were seen in the RFK group during 3-months of follow up. In 7 out of 158 vertebrae (4.4%) a cement leakage into the disc or lateral wall could be determined by radiograph postoperatively. Conclusion. Radiofrequency Kyphoplasty is a very safe and effective minimally invasive procedure for the treatment of osteolytic vertebral fractures. Radiofrequency Kyphoplasty shows excellent clinical and radiological results in the 3 and 6 months follow up. Site specific cavity creation and delivery of ultra-high viscosity cement in RF Kyphoplasty with extended working time resulted in the added benefits of height restoration and lower cement leakages intra-operatively

Introduction. The MITCH PCR is an anatomic, flexible, horse-shoe shaped acetabular component, with 2 polar fins. The rationale of the PCR cup design is to reproduce a near-physiological stress distribution in the bone adjacent to the prosthesis. The thin composite cup is designed to fuse and flex in harmony with the surrounding bony structure. Only the pathological acetabular cartilage and underlying subchondral bone of the horseshoe-shaped, load-bearing portion of the acetabular socket is replaced, thus preserving viable bone stock. The PCR is manufactured from injection moulded carbon fibre reinforced polyetheretherketone (PEEK), with a two layer outer surface comprising hydroxyapatite and plasma sprayed commercially pure titanium. It is implanted in conjunction with a large diameter low wear femoral head, producing a bearing that will generate minimal wear debris with relatively inert particles. Pre-clinical mechanical testing, finite element analysis and biocompatibility studies have been undertaken. FEA evaluation predicts preservation of host bone density in the load bearing segments. A pilot clinical study was completed on a proto-type version of the PCR cup (the “Cambridge” cup), achieving excellent 5 and 10 year results. Subjects and Methods. We report the three-year results from a two-centre, prospective clinical evaluation study of the MITCH PCR cup. Patient outcome has been assessed using standardised clinical and radiological examinations and validated questionnaires. The change in physical level of activity and quality of life has been assessed using the Oxford Hip Score, Harris Hip score and the EuroQol-5D score, at scheduled time-points. Serial radiographs have been analysed to monitor the fixation and stability of the components. Results and Conclusions. In total 25 PCR cups were implanted by 3 surgeons. There were 12 men and 13 women. The mean patient age at time of surgery was 67 years (range 57–74). An Accolade TMZF stem was used as the femoral component in 19 patients and an Exeter stem in 6. The mean Oxford Hip score improved from 19.8 pre-operatively to 45 at the latest follow-up. The mean Euroqol-5D score improved from 62.6 to 83.6 and the Harris Hip score improved from 49.9 to 90.6. Three adverse events were noted in 2 patients (2 chest infections and 1 deep vein thrombosis). One revision of the acetabular component was performed at 21 months for squeaking. This has been investigated and modification of the articular geometry has resolved the problem on in-vitro testing

Introduction. Osteoarthritis (OA) represents a leading cause of disability and a growing burden on healthcare budgets. OA is particularly vexing for young, active patients who have failed less invasive therapies but are not yet candidates for arthroplasty. Often, patients suffering in this wide therapeutic gap face a debilitating spiral of disease progression, increasing pain, and decreasing activity until they become suitable arthroplasty patients. An implantable load absorber was evaluated for the treatment of medial knee OA in this patient population. Joint overload has been cited as a contributor to OA onset or progression. In response, the KineSpring® System (Moximed, Inc, USA) has been designed to reduce the load acting on the knee. The absorber is implanted in the subcutaneous tissue without violating the joint capsule, thus preserving the option of future arthroplasty. The implant is particularly useful for young, active patients, given the reversibility of the procedure and the preservation of normal flexibility and range of motion. Methods and Results. The KineSpring System was implanted in 55 patients, with the longest duration exceeding two years. The treated group had medial knee OA, included younger OA sufferers (range 31–68 years), with a mean BMI > 30kg/m2. Acute implant success, adverse events, and clinical outcomes using validated patient reported outcomes tools were recorded at baseline, post-op, 2 and 6 weeks, and 3, 6, 12 and 24 months post-op. All patients were successfully implanted with a mean procedure time of 76.4 min (range 54–153 minutes). Mean hospital length of stay was 1.7 days (range 1–3 days), and patients recovered rapidly, achieving full weight bearing within 1–2 wks and normal range of motion by 6 weeks. Most patients experienced pain relief and functional improvement with 85% (35/41) reporting none or mild pain on the WOMAC pain subscale and 90% (37/41) reporting functional impairment as none on mild on the WOMAC function subscale at the latest follow-up visit (mean 9.3 ± 3.5 months). Clinically meaningful and statistically significant pain reduction and functional improvement were noted with baseline WOMAC pain scores (0–100 scale) improving from 42.4 to 16.1 (p<0.001) and WOMAC function (0–100 scale) improving from 42.0 to 14.7 (p<0.001) at latest follow-up. Patients reported satisfaction with the implant and its appearance. Conclusions. The KineSpring System preserves natural knee anatomy and kinematics while providing pain reduction and resumption of high activity levels that have proven durable. This device, with these excellent results, fills a major gap in treatment options for young and active OA patients

BACKGROUND. As life expectancy in the population rises, osteoporotic fractures are seen most frequently in the vertebral column. Percutaneous kyphoplasty is increasingly used for pain reduction and stabilization in these patients, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. OBJECTIVE. To clarify whether kyphoplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. MATERIALS & METHODS. From January 2004 to June 2009, 122 patients (31 males and 91 females), from 56 to 85 years old (mean age 68.5) were treated for 165 osteoporotic vertebral fractures of the thoracic or lumbar spine (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Twelve patients (15 fractures) were lost at follow-up period and excluded. Patients were randomly allocated to percutaneous kyphoplasty (75 patients) or conservative treatment by computer-generated randomization codes. All fractures were analyzed for improvement in sagittal alignment (Cobb angle, kyphotic angle, sagittal index, vertebral height); and pain relief at 1, 6, 12, 24 months, as measured by VAS score. RESULTS. Percutaneous kyphoplasty resulted in direct and greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was −6,5 after kyphoplasty and −2.4 after conservative treatment, and between baseline and 1 year was −7.2 after kyphoplasty and −3.8 after conservative treatment. No serious complications or adverse events were reported. Apart from the pain, the patient's ability to ambulate independently and without difficulty, and the need for medications improved significantly (P < 0.001) after kyphoplasty. Vertebral height significantly increased at all postoperative intervals, with 10% height increases in 88% of fractures, in kyphoplasty group at 2 years. There were no severe kyphoplasty-related complications, such as neurological defects, cement leakage or narrowing of the spinal canal whereas additional fractures occurred at the adjacent vertebrae at a rate of 10%. 35% of patients treated conservatively, had limitations in everyday activities the first 6 months, whereas additional fractures occurred at the adjacent vertebrae at a rate of 14%. CONCLUSION. In patients with acute osteoporotic vertebral compression fractures and persistent pain, balloon kyphoplasty is effective and safe. Pain relief after kyphoplasty is immediate, is sustained for at least 2 years, and is significantly greater than that achieved with conservative treatment, at an acceptable cost