This prospective multicentre study was undertaken
to determine segmental movement, disc height and sagittal alignment
after total disc replacement (TDR) in the lumbosacral spine and
to assess the correlation of biomechanical properties to clinical
outcomes. A total of 173 patients with degenerative disc disease and low
back pain for more than one year were randomised to receive either
TDR or multidisciplinary rehabilitation (MDR). Segmental movement
in the sagittal plane and disc height were measured using distortion
compensated roentgen analysis (DCRA) comparing radiographs in active flexion
and extension. Correlation analysis between the range of movement
or disc height and patient-reported outcomes was performed in both
groups. After two years, no significant change in movement in the
sagittal plane was found in segments with TDR or between the two
treatment groups. It remained the same or increased slightly in
untreated segments in the TDR group and in this group there was
a significant increase in disc height in the operated segments.
There was no correlation between segmental movement or disc height
and patient-reported outcomes in either group. In this study, insertion of an intervertebral disc prosthesis
TDR did not increase movement in the sagittal plane and segmental
movement did not correlate with patient-reported outcomes. This
suggests that in the lumbar spine the movement preserving properties
of TDR are not major determinants of clinical outcomes. Cite this article:
Patient-reported outcome measures (PROMs) are
increasingly being used to assess functional outcome and patient satisfaction.
They provide a framework for comparisons between surgical units,
and individual surgeons for benchmarking and financial remuneration.
Better performance may bring the reward of more customers as patients and
commissioners seek out high performers for their elective procedures.
Using National Joint Registry (NJR) data linked to PROMs we identified
22 691 primary total knee replacements (TKRs) undertaken for osteoarthritis
in England and Wales between August 2008 and February 2011, and
identified the surgical factors that influenced the improvements
in the Oxford knee score (OKS) and EuroQol-5D (EQ-5D) assessment
using multiple regression analysis. After correction for patient
factors the only surgical factors that influenced PROMs were implant
brand and hospital type (both p <
0.001). However, the effects
of surgical factors upon the PROMs were modest compared with patient
factors. For both the OKS and the EQ-5D the most important factors
influencing the improvement in PROMs were the corresponding pre-operative
score and the patient’s general health status. Despite having only
a small effect on PROMs, this study has shown that both implant
brand and hospital type do influence reported subjective functional
scores following TKR. In the current climate of financial austerity,
proposed performance-based remuneration and wider patient choice,
it would seem unwise to ignore these effects and the influence of
a range of additional patient factors.
The responsiveness of the Manchester–Oxford Foot
Questionnaire (MOXFQ) was compared with foot/ankle-specific and
generic outcome measures used to assess all surgery of the foot
and ankle. We recruited 671 consecutive adult patients awaiting
foot or ankle surgery, of whom 427 (63.6%) were female, with a mean
age of 52.8 years (18 to 89). They independently completed the MOXFQ,
Short-Form 36 (SF-36) and EuroQol (EQ-5D) questionnaires pre-operatively
and at a mean of nine months (3.8 to 14.4) post-operatively. Foot/ankle
surgeons assessed American Orthopaedic Foot and Ankle Society (AOFAS)
scores corresponding to four foot/ankle regions. A transition item measured
perceived changes in foot/ankle problems post-surgery. Of 628 eligible
patients proceeding to surgery, 491 (78%) completed questionnaires
and 262 (42%) received clinical assessments both pre- and post-operatively. The
regions receiving surgery were: multiple/whole foot in eight (1.3%),
ankle/hindfoot in 292 (46.5%), mid-foot in 21 (3.3%), hallux in
196 (31.2%), and lesser toes in 111 (17.7%). Foot/ankle-specific
MOXFQ, AOFAS and EQ-5D domains produced larger effect sizes (>
0.8)
than any SF-36 domains, suggesting superior responsiveness. In analyses
that anchored change in scores and effect sizes to patients’ responses
to a transition item about their foot/ankle problems, the MOXFQ
performed well. The SF-36 and EQ-5D performed poorly. Similar analyses,
conducted within foot-region based sub-groups of patients, found
that the responsiveness of the MOXFQ was good compared with the
AOFAS. This evidence supports the MOXFQ’s suitability for assessing
all foot and ankle surgery.
We present the development and results of a nationwide, prospective, observational follow-up programme including patient-reported outcome measures (PROMs) for the Swedish Hip Arthroplasty Register. The programme started in 2002 and has gradually expanded to include all units performing total hip replacement in Sweden. The self-administered PROMs protocol comprises the EQ-5D instrument, the Charnley class categorisation and visual analogue scales for pain and satisfaction. These current analyses include 34 960 total hip replacements with complete pre- and one-year post-operative questionnaires. Patients eligible for total hip replacement generally report low health-related quality of life and suffer from pain. One year post-operatively the mean EQ-5D index increased to above the level of an age- and gender-matched population, with a considerable reduction of pain (p <
0.001). Females, younger patients and those with Charnley category C reported a lower EQ-5D index pre-operatively than males, older patients and Charnley category A or B, respectively (all p <
0.001). In a multivariable regression analysis Charnley category C, male gender and higher age were associated with less improvement in health-related quality of life (p <
0.001). Nationwide implementation of a PROMs programme requires a structured organisation and effective data capture. Patients’ response rates to the Registry are good. The continuous collection of PROMs permits local and national improvement work and allows for further health-economic evaluation.
Our aim in this pilot study was to evaluate the fixation of, the bone remodelling around, and the clinical outcome after surgery of a new, uncemented, fully hydroxyapatite-coated, collared and tapered femoral component, designed specifically for elderly patients with a fracture of the femoral neck. We enrolled 50 patients, of at least 70 years of age, with an acute displaced fracture of the femoral neck in this prospective single-series study. They received a total hip replacement using the new component and were followed up regularly for two years. Fixation was evaluated by radiostereometric analysis and bone remodelling by dual-energy x-ray absorptiometry. Hip function and the health-related quality of life were assessed using the Harris hip score and the EuroQol-5D. Up to six weeks post-operatively there was a mean subsidence of 0.2 mm (−2.1 to +0.5) and a retroversion of a mean of 1.2° (−8.2° to +1.5°). No component migrated after three months. The patients had a continuous loss of peri-prosthetic bone which amounted to a mean of 16% (−49% to +10%) at two years. The mean Harris hip score was 82 (51 to 100) after two years. The two-year results from this pilot study indicate that this new, uncemented femoral component can be used for elderly patients with osteoporotic fractures of the femoral neck.
We investigated the pre-operative and one-year post-operative health-related quality of life (HRQOL) outcome by using a Euroqol (EQ-5D) questionnaire in 263 patients who had undergone surgery for herniation of a lumbar disc. Data from the National Swedish Register for lumbar spinal surgery between 2001 and 2002 were used and, in addition, a comparison between our cohort and a Swedish EQ-5D population survey was performed. We analysed the pre- and post-operative quality of life data, age, gender, smoking habits, pain and walking capacity. The mean age of the patients was 42 years (20 to 66); 155 (59%) were men and 69 (26%) smoked. Pre-operatively, 72 (17%) could walk at least 1 km compared with 200 (76%) postoperatively. The mean EQ-5D score improved from 0.29 to 0.70, and the HRQOL improved in 195 (74%) of the patients. The pre-operative score did not influence the post-operative score. In most patients, all five EQ-5D dimensions improved, but did not reach the level reported by an age- and gender-matched population sample (mean difference 0.17). Predictors for poor outcome were smoking, a short pre-operative walking distance, and a long history of back pain.