Study of an All Polyethylene Tibial Component
- Conditions
- Knee Replacement
- Interventions
- Device: All-polyethylene tibia (Aesculap AG)
- Registration Number
- NCT02540902
- Lead Sponsor
- Golden Jubilee National Hospital
- Brief Summary
This will be a prospective single cohort investigation of the Columbus all polyethylene tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of the project is to determine post-operative outcome of the all polyethylene tibia up to two years.
- Detailed Description
Thirty consecutive TKA patients under the care of two orthopaedic consultants at the Golden Jubilee National Hospital who meet the inclusion/exclusion criteria will be recruited to the study and will be given the all polyethylene tibia. Participants will return for their standard postoperative followup appointments (6 weeks and 1 year post-operatively). In addition to standard care, a bone density scan using dual energy x-ray absorptiometery (DXA) will be done as part of the 6 weeks post-operative follow-up. A second DXA scan will be done at an additional appointment at the hospital between 18 and 24 months post-operatively for a bone density scan which is not part of standard care.
The data which will be analysed will be the results of the bone scan, computer generated data about the range of movement (RoM) and alignment of the operated knee collected as part of the operation, the RoM, clinical outcome and satisfaction data collected at the pre-operative assessment and post-operative followups, pre- and post-operative x-rays, complications, survivorship and surgeon experience of using the all polyethylene tibia. These data will be investigated to see if the all polyethylene tibia has satisfactory outcomes with no adverse effects.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Unilateral TKA
- Aged 70 year or older
- BMI < 37.5
- Suitable to receive the study implant
- Revision of existing knee replacement
- Previous lower limb replacement
- Proximal tibial bone defects
- Diagnosed osteopenia or osteoporosis
- Unable to give informed consent
- Unwilling to take part
- Unable to return to the Golden Jubilee National Hospital for followup appointments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All-poly All-polyethylene tibia (Aesculap AG) Knee arthroplasty with all-polyethylene tibia
- Primary Outcome Measures
Name Time Method Bone mineral density 18 to 24 months post-operatively Measure of peri-prosthetic bone mineral density
- Secondary Outcome Measures
Name Time Method Intra-operative RoM Intra-operative Range of movement of the knee joint measured by the navigation computer during surgery
EQ-5D 1 year General health measure
Patient satisfaction 1 year Patient satisfaction with surgery (Scale: 0 to 10, 0 = not satisfied, 10 = very satisfied)
Oxford Knee Score 1 year Clinical outcome measure
Leg alignment 1 year Leg alignment measured from long leg x-rays
Bone condition 1 year Signs of osteolysis from knee x-rays
Surgeon feedback from surgery intra-operative Surgeon experience and issues with using all-polyethylene tibia using an un-validated questionnaire.
Peri-prosthetic lucency 1 year Radiolucent lines (\>2mm wide) around the component which may indicate component loosening
Intra-operative alignment Intra-operative The leg alignment measured by the navigation computer during surgery.
RoM 1 year Active range of motion of the knee joint
Complications 1 year Any post-operative complications as a result of surgery, e.g. infection, revision, aseptic loosening.
Implant survivorship 18 to 24 months Percentage of implants still in situ over time.
Component position 1 year Migration of the component over time measured from x-rays
Trial Locations
- Locations (1)
Golden Jubilee National Hospital
🇬🇧Clydebank, West Dunbartonshire, United Kingdom