Knee ReplacementNCT02540902
Study of an All Polyethylene Tibial Component
A study testing All-polyethylene tibia (Aesculap AG) in people with Knee Replacement, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Knee Replacement
- What is being tested?
- All-polyethylene tibia (Aesculap AG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Unilateral TKA
- Aged 70 year or older
- BMI < 37.5
- Suitable to receive the study implant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Golden Jubilee National Hospital
Clydebank, West Dunbartonshire, G81 4DY
About this study
Official title: A Prospective Study of an All Polyethylene Tibial Component Used in Total Knee Arthroplasty Surgery
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.
Read the 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.
- Conditions
- Knee Replacement
- Being tested
- All-polyethylene tibia (Aesculap AG)
- Keywords
- Knee replacement, Knee arthroplasty, All-polyethylene tibia, Bone density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-polyethylene tibia (Aesculap AG)Device
Also called Aesculap All Poly Tibia Plateau Columbus CR DD, NN1200-NN1203, NN1210-NN1213, NN1220-NN1223, NN1230-NN1233, NN1240-NN1243, NN1250-NN1253
Implantation of an all polyethylene tibial component.
| Study group | Role | What they receive |
|---|---|---|
| All-poly | Experimental | Knee arthroplasty with all-polyethylene tibia Receives: Device: All-polyethylene tibia (Aesculap AG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measure of peri-prosthetic bone mineral density
Measured: 18 to 24 months post-operatively
Secondary outcomes (13)
Intra-operative RoM
Range of movement of the knee joint measured by the navigation computer during surgery
Measured: Intra-operative
Intra-operative alignment
The leg alignment measured by the navigation computer during surgery.
Measured: Intra-operative
RoM
Active range of motion of the knee joint
Measured: 1 year
Oxford Knee Score
Clinical outcome measure
Measured: 1 year
EQ-5D
General health measure
Measured: 1 year
Patient satisfaction
Patient satisfaction with surgery (Scale: 0 to 10, 0 = not satisfied, 10 = very satisfied)
Measured: 1 year
Leg alignment
Leg alignment measured from long leg x-rays
Measured: 1 year
Bone condition
Signs of osteolysis from knee x-rays
Measured: 1 year
Complications
Any post-operative complications as a result of surgery, e.g. infection, revision, aseptic loosening.
Measured: 1 year
Implant survivorship
Percentage of implants still in situ over time.
Measured: 18 to 24 months
Surgeon feedback from surgery
Surgeon experience and issues with using all-polyethylene tibia using an un-validated questionnaire.
Measured: intra-operative
Component position
Migration of the component over time measured from x-rays
Measured: 1 year
Peri-prosthetic lucency
Radiolucent lines (>2mm wide) around the component which may indicate component loosening
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startOct 2015
- Primary completion12 Apr 2019
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Collaborators
- Aesculap AG
- Responsible party
- Sponsor
- Investigators
- Frederic Picard, MD, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540902
- Sponsor's protocol ID
- Ortho 15-06
- Status last verified
- May 2019
- First submitted
- 11 Aug 2015
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of an All Polyethylene Tibial Component Used in Total Knee Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT02540902
- Acronym / sponsor ID
- Ortho 15-06
- Conditions
- Knee Replacement
- Keywords
- Knee replacement, Knee arthroplasty, All-polyethylene tibia, Bone density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- Aesculap AG
- Study start
- Oct 2015 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- Oct 2019 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All-poly | Experimental | Device: All-polyethylene tibia (Aesculap AG)Knee arthroplasty with all-polyethylene tibia |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Unilateral TKA
- Aged 70 year or older
- BMI < 37.5
- Suitable to receive the study implant
Key exclusion criteria (7 listed)
- Revision of existing knee replacement
- Previous lower limb replacement
- Proximal tibial bone defects
- Diagnosed osteopenia or osteoporosis
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All-polyethylene tibia (Aesculap AG)Also: Aesculap All Poly Tibia Plateau Columbus CR DD, NN1200-NN1203, NN1210-NN1213, NN1220-NN1223, NN1230-NN1233, NN1240-NN1243, NN1250-NN1253Implantation of an all polyethylene tibial component. | Device | All-poly |
Primary outcome
Bone mineral density
Time frame: 18 to 24 months post-operatively
Measure of peri-prosthetic bone mineral density
13 secondary outcomes
Intra-operative RoM
Time frame: Intra-operative
Intra-operative alignment
Time frame: Intra-operative
RoM
Time frame: 1 year
Oxford Knee Score
Time frame: 1 year
EQ-5D
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Leg alignment
Time frame: 1 year
Bone condition
Time frame: 1 year
Complications
Time frame: 1 year
Implant survivorship
Time frame: 18 to 24 months
Surgeon feedback from surgery
Time frame: intra-operative
Component position
Time frame: 1 year
Peri-prosthetic lucency
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Individual participant dataSharing planned: No
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Chronic Post-surgical Pain, Chronic Post Operative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic Picard, MD principal investigator
Golden Jubilee National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All-polyethylene tibia (Aesculap AG) in people with Knee Replacement, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 18 to 24 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.