Effectiveness and Cost-effectiveness of Outpatient Physiotherapy After Knee Replacement for Osteoarthritis: Study Protocol for a Randomised Controlled Trial

Background: Primary total knee replacement is a common operation that is performed to provide pain relief and restore functional ability. Inpatient physiotherapy is routinely provided after surgery to enhance recovery prior to hospital discharge. However, international variation exists in the provision of outpatient physiotherapy after hospital discharge. While evidence indicates that outpatient physiotherapy can improve short-term function, the longer term benefits are unknown. The aim of this randomised controlled trial is to evaluate the long-term clinical effectiveness and cost-effectiveness of a 6-week group-based outpatient physiotherapy intervention following knee replacement. Methods/design: Two hundred and fifty-six patients waiting for knee replacement because of osteoarthritis will be recruited from two orthopaedic centres. Participants randomised to the usual-care group (n = 128) will be given a booklet about exercise and referred for physiotherapy if deemed appropriate by the clinical care team. The intervention group (n = 128) will receive the same usual care and additionally be invited to attend a group-based outpatient physiotherapy class starting 6 weeks after surgery. The 1-hour class will be run on a weekly basis over 6 weeks and will involve task-orientated and individualised exercises. The primary outcome will be the Lower Extremity Functional Scale at 12 months post-operative. Secondary outcomes include: quality of life, knee pain and function, depression, anxiety and satisfaction. Data collection will be by questionnaire prior to surgery and 3, 6 and 12 months after surgery and will include a resource-use questionnaire to enable a trial-based economic evaluation. Trial participation and satisfaction with the classes will be evaluated through structured telephone interviews. The primary statistical and economic analyses will be conducted on an intention-to-treat basis with and without imputation of missing data. The primary economic result will estimate the incremental cost per quality-adjusted life year gained from this intervention from a National Health Services (NHS) and personal social services perspective. Discussion: This research aims to benefit patients and the NHS by providing evidence on the long-term effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement. If the intervention is found to be effective and cost-effective, implementation into clinical practice could lead to improvement in patients’ outcomes and improved health care resource efficiency

Delineating the extent of anterior capsulorhexis with gentian violet using capsulorhexis marker: a preliminary study of efficacy and toxicity in an animal model

Mohamed Abdel Moneim Hassaballa, Amr Abd el-Latif OsmanDepartment of Ophthalmology, Faculty of Medicine, Cairo University, Cairo, EgyptBackground: The purpose of this study was to evaluate the efficacy and safety of a new instrument to optimize the size, shape, and centration of anterior capsulorhexis.Methods: The study was divided into two parts. The first part was done in 10 goats' eyes. A specially designed capsulorhexis marker was used. The lower edge of the instrument was stained by gentian violet and then applied to the anterior capsule to produce a circular mark of 5.5 mm. In five eyes, the gentian violet was applied to the marker using a corneal marking pen; in the remaining five eyes, the gentian violet was applied using a corneal marking pad. In the second part, the toxicity of gentian violet was tested as follows: ten albino rabbits received a gentian violet injection into the anterior chamber in one eye (experimental group) and an equal volume of balanced salt solution in the fellow eye (control group). Five rabbits were sacrificed one day after surgery and the remaining five rabbits after one week.Results: In the first part, there was no difficulty in the introduction or removal of the instrument from all eyes. In the first two eyes, the circular mark was diffuse due to sliding of the marker on the surface of the anterior capsule. In the remaining eight eyes, there was a well-centered, rounded mark which was adequately stained. In the second part, there was no histopathological evidence of corneal toxicity in either group. There was loss of ganglion cells from the neurosensory retina one day after surgery in one eye from the experimental group. At one week, there was no evidence of retinal toxicity in any of the rabbits.Conclusion: This capsulorhexis marker can guide the surgeon to a better centration and proper sizing of anterior capsulorhexis using gentian violet staining. More refinement of the instrument is needed to be able to use it in human eyes.Keywords: capsulorhexis, gentian violet, marke