None listed
Conditions
Brief summary
Study design: Prospective, multi-centre, randomised, clinical study. The study will enrol 100 patients over a 12-month recruitment period between surgeons at up to three centres. Objectives: To determine the relationship between Surgical Technique (workflow) and patient reported outcomes after total knee arthroplasty (TKA) utilising computer navigation, comparing tibia cut first with ligament balancing technique to measured femoral cuts technique. To investigate if patient range of motion and component alignment is affected by the order of workflow. To investigate if the order of surgical cuts during total knee replacement affects other parameters such as patient satisfaction. The study will also demonstrate safety, and equivalent clinical outcomes on pain and function to other published data. Groups: Apex Total Knee Replacement using Computer Navigation utilising Tibial Cut First. Apex Total Knee Replacement using Computer Navigation utilising Measured Femoral Cuts First. Number of subjects to be enrolled: 100 patients will be enrolled into this study. Medical Devices: The Apex Knee is intended for use as a primary total knee replacement device consisting of a femoral, tibial, tibial bearing and optional patellar component. The BTS G-walk is a wireless sensor that is placed around the waist with an ergonomic belt to analyse the walking pattern. Regulatory status: The Apex Knee is CE marked, TGA approved and has a rebate code on the Prostheses List. Clinical evaluations: Standard, functional parameters will be assessed preoperatively, and post-operatively at 6 weeks, 3months, 1 year, 2years. Published early results at 1 year then mid-term and long term results after 2 and more years Patient outcome assessments: The Oxford Knee Score and RAND SF36 operatively at 6 weeks, 3months, 1 year and 2 years. Radiographic evaluations: X-Rays will be assessed pre-operatively, post-operatively, at 12 months and 2 years to evaluate femoral and tibial components orientation and inclination.
Interventions
Tibial First:
Patients will undergo primary total knee arthroplasty using the Apex Knee system and the Praxim navigation system from Global Orthopaedic Technology. The first cut is performed on the tibial site and the following femoral cuts are determined according to the mediolateral soft tissue tension.
The Praxim 'Registered Trademark' OmniNav 'Trademark' Navigation system is a complete computer surgical navigation
system for use with the APEX Knee. The iBlock 'Registered Trademark' is an in
Tibial First: Patients will undergo primary total knee arthroplasty using the Apex Knee system and the Praxim navigation system from Global Orthopaedic Technology. The first cut is performed on the tibial site and the following femoral cuts are determined according to the mediolateral soft tissue tension. The Praxim 'Registered Trademark' OmniNav 'Trademark' Navigation system is a complete computer surgical navigation system for use with the APEX Knee. The iBlock 'Registered Trademark' is an intelligent instrument allowing intraoperative customisation in total knee arthroplasty using real-time virtual planning technology followed by automated placement of the cutting guide. The Apex Knee reconstruction system has been designed to precisely match the size of the tibial insert to the femoral component. The Apex 'Trademark' Knee System offers both porous coated uncemented and cemented versions of its tibial and femoral components. The Apex Knee reconstruction system is a commercially available, TGA ( Therapeutic Goods Administration) listed device. The BTS G-walk is a wireless sensor that is placed around the waist with an ergonomic belt to analyse the walking pattern. BTS G-Walk 'Registered Trademark' enables functional analysis with objective, accurate and quantitative data. BTS G-WALK 'Registered Trademark' analyzes the walking pattern applying a suite of specific protocols, validated through clinical studies. .X-Rays will be assessed pre-operatively, post-operatively, at 12 months and 2 years to evaluate femoral and tibial components orientation and inclination.
Sponsors
Global Orthopaedic Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has diagnosis of Osteoarthritis of the knee eligible for total knee replacement based on history, physical examination and radiological evaluation. 2. The individual has signed a Participant Informed Consent (PIC), specific to this study, and approved by the Human Research Ethics Committee (HREC) 3. The individual is over 18 years of age. 4. The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion criteria
1. The individual has an active infection within the affected knee joint. 2. The individual has a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device. 3. The individual is unable to return for follow-up visits as outlined in the protocol. 4. The individual has inflammatory arthritis 5. The individual has had a previous Patellectomy 6. The individual has had a previous proximal tibial or distal femoral osteotomy. 7. The individual has Extra-articular deformity 8. The individual has Neuroarthopathy 9. The individual does not speak, read or comprehend the English language.
Outcome results
None listed