A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment with Mechanical Axis Alignment on Forgotten Joint Score after Total Knee Arthroplasty.

Gavin Clark0 个研究点目标入组 100 人开始时间: 2021年1月25日最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•Patient has symptomatic knee osteoarthritis requiring primary TKA
•-Patient and surgeon are in agreement that TKA is the most appropriate treatment
•-Patient is fit for surgical intervention following review by surgeon
•-Patient is between 45-75 years of age at time of surgery, computer literate, and able to complete patient reported outcome measures independently.
•-Patient must be capable of giving informed consent and agree to comply with the postoperative review program.
•-Patient must be a permanent resident in an area accessible to the study site
•-Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
•-Patient has tried non-pharmacologic therapy’s including ; patient education, self-management programs, aerobic exercise, weight loss, physiotherapy and occupational therapy
•-Patient has tried appropriate pharmacologic therapies including ; regular paracetamol and NSAIDS if appropriate

•- Patient is not suitable for routine primary TKA. E.g. patient has ligament deficiency that requires a constrained prosthesis
•- Interoperative requirement for a more constrained implant.
•- Intraoperative requirement for the PCL to be released. These patients will be still included in the study, but analyzed with an intention to treat principal.
•- Patient has bone loss that requires augmentation
•- Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA (eg. Post high tibial or distal femoral osteotomy)
•- Patient requires a polyethylene inset of 13mm or greater.
•- Patient is immobile or has another neurological condition affecting musculoskeletal function
•- Patient is less than 44 years of age or greater than 76 years of age
•- Patient is a compensable patient. I.e. Worker’s compensation claim or motor vehicle accident.
•- Patient is already enrolled on another concurrent clinical trial
•- Patient is unable or unwilling to sign the informed consent form specific to this study
•- Patient is unable to attend the follow-up program
•- Patient is non-resident in local area or expected to leave the catchment area postoperatively
•- Patients who lacks capacity to provide consent, or the ability to understand the study protocol due to a cognitive condition (eg. Dementia)
•- Patient is unable to communicate effectively in English.

发起方

Gavin Clark