Osteoarthritis of the knee joint Musculoskeletal Diseases Musculoskeletal/ Arthrosis
Conditions
Interventions
Participant are randomly allocated to receive either the JOURNEY II Bi Cruciate Stabilised (BCS) or the GENESIS II total knee implant.
The JOURNEY II BCS knee implant (intervention) has been structura
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Listed for a primary total knee replacement (TKR) at the Norfolk and Norwich University Hospital (may be referred to Spire Norwich for the operation to take place) 2. Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments 3. Aged 18 or over 4. Patient willing to provide full informed consent to the trial
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 22/02/2019: 1. Listed for a single-stage bilateral TKR procedure 2. Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure 3. Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur 4. Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater 5. Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient’s safety 6. Inflammatory arthritis 7. Previous septic arthritis in the affected knee joint 8. Previous surgery to the collateral ligaments of the affected knee 9. A contralateral total knee replacement that has been implanted less than one year from the date of consultation 10. A contralateral total knee replacement that is severely painful 11. Patients on warfarin or novel oral anticoagulants (NOACs) 12. Will not be resident in the catchment area for NNUH for at least 6 months post-surgery 13. Undertaking the surgery as a private patient 14. Patients who, in the opinion of the clinical staff, do not have capacity to consent 15. Patients who are pregnant 16. Unable to understand written and spoken English Previous exclusion criteria: 1. Listed for a single-stage bilateral TKR procedure 2. Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure 3. BMI greater than 35 4. Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur 5. Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater 6. Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient’s safety 7. Inflammatory arthritis 8. Previous septic arthritis 9. Previous knee surgery other than diagnostic arthroscopy or menisectomy 10. Patients on warfarin 11. Will not be resident in the catchment area for NNUH for at least 6 months post-surgery 12. Undertaking the surgery as a private patient 13. Patients who, in the opinion of the clinical staff, do not have capacity to consent 14. Patients who are pregnant 15. Unable to understand written and spoken English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Function and pain is measured using Oxford Knee Score (OKS) at six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/11/2019: Patient reported outcome measures 1. Function and pain is measured using the Oxford Knee Score (OKS) at1 week and 6-8 weeks post-operatively 2. Higher levels of activity and (social) participation is measured using the Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ) at 1 week, 6-8 weeks and 6 months post-operatively 3. Quality of life is measured using EuroQol (EQ- 5D-5L) at 1 week, 6-8 weeks and 6 months post-operatively 4. The patient’ ability to forget about a joint as a result of successful treatment is measured using the Forgotten Joint Score (FJS) at 6-8 weeks and 6 months post-operatively 5. Physical activity is measured using the UCLA activity score at 6-8 weeks and 6 months post-operatively Clinical efficacy outcomes: 1. The clinical efficacy of the arthroplasty is assessed by measuring the Knee Flexion Range of Movement (ROM) on discharge (routine care) at 6-8 weeks and 6 months post-operatively 2. The clinical efficacy of the arthroplasty is assessed by measuring the Knee extension ROM on discharge (routine care) at 6-8 weeks and 6 months post-operatively 3. Evolution of post-operative knee pain is measured using Changes in pain medication at 1 week, 6-8 weeks and 6 months post-operatively 4. The clinical efficacy of the arthroplasty is assessed by collecting arthroplasty related complications during surgery, 1 week, 6-8 weeks and 6 months post-operatively 5. The clinical efficacy of the arthroplasty is assessed by collecting the rate of revision surgery at 1 week, 6-8 weeks and 6 months post-operatively 6. The clinical efficacy of the arthroplasty is assessed by measuring the timed Up and Go at 6-8 weeks and 6 months post-operatively 7. The clinical efficacy of the arthroplasty is assessed by measuring the timed 6 minute walk at 6-8 weeks and 6 months post-operatively 8. The clinical efficacy of the arthroplasty is assessed by collecting the Length of hospital stay, which is an ind | — |
Countries
England, United Kingdom
Contacts
Public ContactIain McNamara
Outcome results
None listed