Background and Aim: SF-36 has been used frequently as a measurement tool to evaluate the effect of total hip arthroplasty (THA) operation on the patient’s quality of life (QoL). There is though a lack of data describing how QoL is affected if the patients have medical co-morbidities before the operation or if they suffer postoperative complications after THA. With this study we wanted to describe the effect on QoL of pre-operative co-morbidity and post-operative surgical and thromboembolic complications after THA.

Material and methods: This study was part of the ESMOS study where 500 consecutive THA patients (both primary and revision THA) were followed prospectively for one year, with the purpose to collect all surgical and thromboembolic events that these patients experienced. The patients were asked to fill in a SF-36 form the day before the operation and one year after the operation. 397 (79.4%) of the patients had two forms sufficient for further data analysis in this study. Co-morbidity data was measured before the operation. Complications were measured with structured interviews by two study persons the fifth postoperative day and at telephone interviews after 3 and 12 month. All reported events were verified according to predefined criteria in the patient’s medical journal.

Results: The majority of the THA patients experienced a gain in their quality of life one year after THA. One year after THA the co-morbid patients had a significantly lower QoL score in all scales, but they still gained from the operation. Patients that experienced either a surgical or a thromboembolic complication had lower SF-36 score one year post-operatively compared to patients without complications. Subgroup analysis revealed that the small group of patients with deep infection, aseptic loosening or re-operation because of malfunction of the prosthesis had a fall in QoL compared to the pre-operative value and scored significantly worse than all other patient groups.

Conclusion: THA is a successful operation when QoL is measured one year postoperatively. Pre-operative co-morbidity and postoperative surgical or thrombo-embolic complications does give a smaller gain in QoL compared to patients without co-morbidity and patients without complications. The small but important group of patients with deep infection, aseptic loosening and malfunction re-operation, were the only to loose QoL one year after THA in this study.

Background: Results after Total Hip Replacement (THR) including prosthetic design, surgical complications and prosthetic survival are frequently reported – however, information on the rate of complications in general is sparse.

Aim and Methods: The aim was to collect information on all complications after THR within the first year after surgery. This study consisted of 500 consecutive patients (386 with primary THR operated due to degenerative osteoarthritis (OA) and 112 with primary THR due to secondary OA or revision THR). These patients were followed by structured interviews at surgery and 3 and 12 months after discharge. Surgical and cardiovascular complications were registered. No interventions related to this study were done. The patients followed the standard care of departments.

Results: 500 patients were included; two withdrew their consent, leaving 498 for the follow up one year after surgery or until death. Of the 498 patients 103 (20.6%) experienced at least one complication related to the operation within the one year observation period. Among the 386 primary THR with degenerative OA the complicationrate was 17.9%.

Of the 498 patients 6.6% experienced one or more symptomatic cardiovascular complications (deep vein thrombosis, pulmonary embolism (PE), myocardial infarction, and stroke, transient ischemic attack or retinal vein thrombosis). In the degenerative OA group 4.7% (95% Cl: 2.6–6.8%) had a cardiovascular event and in the secondary OA + revision group the rate was 13.4% (95% Cl: 10.2–16.6). The rate of complications directly related to the surgery (dislocation, perioperative fracture, bleeding, aseptic loosening, deep infection, peroneal palsy or superficial wound infection) was 15.4% (95% Cl: 12.3–18.6). In the degenerative OA and secondary OA/revision group the rates were: 14.2% and 19.6% respectively. Nine (1.8%) patients died, five of cardiovascular reasons (disseminated intravascular coagulation, PE followed by renal failure, PE followed by cerebral ischemia and stroke), the first three in close relation to the operation.

Discussion: A complication-rate of 20.6% as found in the present study seems to be very high. There is no reason to think that these numbers are not correct. To our knowledge, only one other study has been published with data about complications in general (Williams O., J Arthroplasty17:165–171, 2002). Their results are based on a mix of hospital file data, patient and general practitioner questionnaires with varying response rates – and their findings, although a bit lower in number, support the data from this study. The present study indicates, that there is a need for continuous registration of these common complications– even in the group of primary THR due to degenerative osteoarthritis, usually thought of as being the least complicated. The complication rate must be included in the information given to patients offered THR.

Background: Data on thromboembolic complications (TEC) following major orthopaedic surgery are generally obtained retrospectively from registries or prospectively from large industry-sponsored international multicentre trials. However, the results may differ from those observed in unselected patients in routine operations performed by orthopaedic surgeons. The purpose of the ESMOS study was to describe the number and time of onset of serious symptomatic arterial and venous TEC within 90 days after surgery in an unselected population of patients undergoing total hip replacement (THR).

Patients and methods: A total of 500 (430 primary THR and 70 revision THR) consecutive patients were included in the study performed between January 2004 and May 2005 in Frederiksborg County (Denmark). They were to be followed for 90 days after surgery. Patients were interviewed before surgery for medical history and on days 5 (while in hospital) and 90 (by telephone call) for signs and symptoms of acute myocardial infarction (AMI), pulmonary embolism (PE), deep-vein thrombosis (DVT), transitory cerebral ischemia (TCI)/stroke and retinal vein thrombosis (RVT). The validity of the events was confirmed using files from hospital, general practitioner and international criteria.

Results: Overall, 498 patients were followed-up for 90 days, 2 patients having withdrawn consent. In-hospital pharmacological thromboprophylaxis was performed in 499 patients. Twenty-four patients (4.8%) experienced at least one serious TEC up to day 90: 2 (0.4%) patients died from surgical-related complications (no autopsy was performed); 1 (0.2%) patient experienced AMI, 5 (1.0%) had PE, 10 (2.0%) DVT, 4 (0.8%) TCI, and 2 (0.4%) RVT. Moreover, 2 patients experienced two TEC: AMI followed by TCI in a first patient, PE and TCI in a second patient. The first event occurred up to day 5 in 9 patients (38%) and after day 5 in 15 patients (62%). Five patients (1%) had clinically relevant bleeding complications: 3 patients had a single, minor, upper gastrointestinal bleeding episode while in hospital, one patient developed a huge expanding haematoma at the operation site treated with hip spica and another patient a peritoneal haematoma leading to re-operation.

Conclusion: This study performed in an unselected population clearly shows that THR still results in serious TEC in spite of a wide use of modern anaesthesia techniques, thrombosis prophylaxis and early mobilisation. In the future, we need to better identify at-risk patients in order to optimise their management, in particular post-discharge care, and reduce the risk of serious TEC.

To target postoperative patients in need for prolonged pharmacologic thromboprophylaxis due to persistent coagulation activation, we developed and evaluated a qualitative test method, which detects the urinary excretion of prothrombin fragment 1+2 (uF1+2). The test was developed as a dip-stick device consisting of a one step rapid lateral flow immunoassay with visual readout on one test line and one control line. The assay time was between 5 and 10 minutes.

Spot urine samples were collected in 113 patients undergoing elective hip arthroplasty preoperatively and on day 5 after operation. Specimens were frozen immediately and stored until batch analysis. Pharmacologic thromboprophylaxis was administered according to national guidelines until day 7±2 after the operation. The results of the new dip-stick device were compared with the results of a laboratory based enzyme-linked-immunosorbent-assay (ELISA) method and a predetermined cut-off value. Patients were followed for development of vascular thrombotic complications/unexpected death until day 90 after the operation.

10 (8.8%) patients experienced an event during the study: 2 (1.8%) died unexpectedly and 8 (7.1%) had a vascular thrombotic event. All patients with clinical events had significantly raised postoperative levels of uF1+2. The clinical accuracy of the dip-stick test was acceptable with a sensitivity of 100% and a negative predictive value of 100%. Compared to the standard ELISA method the dip-stick test had a sensitivity of 93% and a specificity of 48%.

Laboratory ELISA analysis of urinary excretion of uF1+2 is neither feasible nor applicable in postoperative patients. Bed-side testing of persistent coagulation activation, however, could help to determine the need for prolonged thromboprophylaxis. The new dip-stick urine test was very easy to use, had a high negative predictive value and sensitivity and thus appears to be safe. However, the number of false positive test results prompts a fine-tuning of the test device. In terms of clinical applicability the test was acceptable. The study showed that about one third of the patients could be excluded from further extension of thromboprophylaxis beyond the first week.