None listed
Conditions
Brief summary
This research project is a prospective, randomised clinical study. The primary purpose of this study is to evaluate the change in medial joint-line position (JLP) of patients implanted with the Unity Total Knee System, in both flexion and extension, from preoperative to six months postoperative. A comparison of the change in JLP of patients having received the Posterior Stabilised versus the Cruciate Retaining surgical technique will be conducted. Secondary objectives are to track clinical outcomes, functional results and imaging assessments of patients implanted with the Unity Total Knee System over a 5-year follow-up period. The study will require 150 participants, equally randomised to receive either the Posterior Stabilised (PS) or Cruciate Retaining (CR) surgical technique. Both PS and CR techniques are reasonable standards of care employed on the basis of surgeon preference. RSA analysis will be performed on a randomised cohort 100 study participants (50 CR and 50 PS). Participants will be assessed preoperatively and postoperatively at discharge, 6 weeks, 6 months, 1 year, 2, 3 and 5 years. All Corin Unity Study procedures adhere to the standard operating procedures at the International Musculoskeletal Research Institute Inc.
Interventions
The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty.
The Unity Total Knee System is provided in two variants, Cruciate Retaining (CR) and Posterior Stabilised (PS) and is intended for cemented, single use only. The system also provides augment components including femoral augments, tibial augments stem extensions, and offset
The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Total Knee System is provided in two variants, Cruciate Retaining (CR) and Posterior Stabilised (PS) and is intended for cemented, single use only. The system also provides augment components including femoral augments, tibial augments stem extensions, and offset connections. The Unity Total Knee System is intended for use in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components. The approximate duration of the surgical procedure of both the CR and PS surgical techniques is 60 to 90 minutes.
Sponsors
International Musculoskeletal Research Institute (IMRI)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Selection of participants for this study will be in accordance with the following inclusion criteria: 1. The patient must be listed for a primary total knee replacement using the Corin Unity TKR System, according to the product ‘Instructions for Use’: - Degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. - Post-traumatic loss of knee joint configuration and function. - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function. 2. The patient must give signed informed consent to participate in the study. 3. The patient must be able to understand all that is expected of them and be able to comply with the study protocol. 4. Male and female patients who are skeletally mature.
Exclusion criteria
Exclusion criteria are in accordance with contraindications for the Unity Total Knee System. 1. Any patient with a total knee replacement not implanted with a Corin Unity TKR. 2. Any patient with severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity. 3. Any patient with a fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques. 4. Any patient with infection/ distant foci of infections. 5. Any patient with osteomyelitis, Osteoporosis, Osteomalacia. 6. Any patient with marked bone loss or bone resorption 7. Any patient with metabolic disorders which may impair bone formation. 8. Any patient with vascular insufficiency. 9. Any patient with muscular atrophy or neuromuscular disease. 10. Any patient with a revision total knee replacement or conversion of a Unicondylar replacement to a total knee replacement on the operative knee. 11. Any patient with fixed flexion contracture greater than 20 degrees. 12. Any patient with varus/valgus deformity greater than 10 degrees. 13. Any case not described in the inclusion criteria. 14. Any patient who cannot or will not provide signed informed consent for participation in the study. 15. Any patient whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems. 16. Patient is female of child-bearing age and not taking contraceptive precautions. 17. Any patient currently a prisoner. 18. Any patient known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes. 19. Any patient currently involved in any personal injury litigation, medical-legal or worker’s compensations claims. 20. Known Posterior Cruciate Ligament (PCL) instability or injury.
Outcome results
None listed