The aim of the HIPGEN consortium is to develop the first cell therapy product for hip fracture patients using PLacental-eXpanded (PLX-PAD) stromal cells. HIPGEN is a multicentre, multinational, randomized, double-blind, placebo-controlled trial. A total of 240 patients aged 60 to 90 years with low-energy femoral neck fractures (FNF) will be allocated to two arms and receive an intramuscular injection of either 150 × 106 PLX-PAD cells or placebo into the medial gluteal muscle after direct lateral implantation of total or hemi hip arthroplasty. Patients will be followed for two years. The primary endpoint is the Short Physical Performance Battery (SPPB) at week 26. Secondary and exploratory endpoints include morphological parameters (lean body mass), functional parameters (abduction and handgrip strength, symmetry in gait, weightbearing), all-cause mortality rate and patient-reported outcome measures (Lower Limb Measure, EuroQol five-dimension questionnaire). Immunological biomarker and in vitro studies will be performed to analyze the PLX-PAD mechanism of action. A sample size of 240 subjects was calculated providing 88% power for the detection of a 1 SPPB point treatment effect for a two-sided test with an α level of 5%.Aims
Methods
Aims. Rotator cuff tendinopathy has a multifactorial origin. Rejecting
the mechanistic theory has also led to abandoning operative treatment
at initial presentation in the first line. Physiotherapy exercise
programmes are the accepted first line treatment. The aim of this
study was to assess the long-term additional benefits of subacromial decompression
in the treatment of rotator cuff tendinopathy. Patients and Methods. This randomised controlled trial of 140 patients (52 men, 88
women, mean age 47.1 years; 18 to 60) with rotator cuff tendinopathy
extended previous work up to a maximum of 13 years. The patients
were randomised into two treatment groups: arthroscopic acromioplasty
and a supervised exercise treatment and a similar supervised exercise
treatment alone. Self-reported pain on a visual analogue scale (VAS)
was the primary outcome measure. Secondary measures were disability,
working ability, pain at night, Shoulder Disability Questionnaire
score and the number of painful days during the three months preceding
the final assessment. Results. A total of 90 patients (64%) returned questionnaires at a mean
12 years after randomisation. On an intention-to-treat basis, both
treatment groups reached statistically significant improvement compared
with the initial VAS for pain, but there was no significant difference
between groups. The same was true in the secondary outcome measures.
Due to group changes, the results were also analysed per protocol:
operated or not. No significant differences between the groups were
found. Conclusion. The natural history of rotator cuff tendinopathy probably plays
a significant role in the results in the long-term. Even though
the patients who underwent
This study compares the cost-effectiveness of
treating dorsally displaced distal radial fractures with a volar
locking plate and percutaneous fixation. It was performed from the
perspective of the National Health Service (NHS) using data from
a single-centre randomised controlled trial. In total 130 patients
(18 to 73 years of age) with a dorsally displaced distal radial
fracture were randomised to treatment with either a volar locking
plate (n = 66) or percutaneous fixation (n = 64). The methodology
was according to National Institute for Health and Care Excellence guidance
for technology appraisals. . There were no significant differences in quality of life scores
between groups at any time point in the study. Both groups returned
to baseline one year post-operatively. . NHS costs for the plate group were significantly higher (p <
0.001, 95% confidence interval 497 to 930). For an additional £713,
fixation with a volar locking plate offered 0.0178 additional quality-adjusted
life years in the year after surgery. The incremental cost-effectiveness
ratio (ICER) for plate fixation relative to percutaneous fixation
at list price was £40 068. When adjusting the prices of the implants
for a 20% hospital discount, the ICER was £31 898. Patients who
underwent plate fixation did not return to work earlier. We found no evidence to support the cost-effectiveness, from
the perspective of the NHS, of fixation using a volar locking plate
over percutaneous fixation for the
Monostotic fibrous dysplasia of the proximal
femur has a variable clinical course, despite its reported limited tendency
to progress. We investigated the natural history and predisposing factors
for progression of dysplasia in a group of 76 patients with a mean
follow-up of 8.5 years (2.0 to 15.2). Of these, 31 (41%) presented
with an asymptomatic incidental lesion while 45 (59%) presented
with pain or a pathological fracture. A group of 23 patients (30%)
underwent early
This systematic review and meta-analysis was conducted to compare open reduction and internal fixation (ORIF) with primary arthrodesis (PA) in the treatment of Lisfranc injuries, regarding patient-reported outcome measures (PROMs), and risk of secondary surgery. The aim was to conclusively determine the best available treatment based on the most complete and recent evidence available. A systematic search was conducted in PubMed, Cochrane Controlled Register of Trials (CENTRAL), EMBASE, CINAHL, PEDro, and SPORTDiscus. Additionally, ongoing trial registers and reference lists of included articles were screened. Risk of bias (RoB) and level of evidence were assessed using the Cochrane risk of bias tools and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. The random and fixed-effect models were used for the statistical analysis.Aims
Methods
The October 2013 Foot &
Ankle Roundup. 360 . looks at:
We compared the long-term outcome in 61 patients (62 fractures) treated operatively or conservatively for an acute fracture of the carpal scaphoid. A total of 30 fractures was randomised to conservative treatment using a cast and 32 to
1. Published comparisons of the results of conservative and
Consecutive patients with a confirmed rupture of at least one of the lateral ligaments of the ankle were randomly assigned to receive either operative or functional treatment. They were evaluated at a median of 8 years (6 to 11). In total, 370 patients were included. Follow-up was available for 317 (86%). Fewer patients allocated to