Osteoarthritis of the KneeNCT02096393
Patient Specific Instrumentation in TKR
A study testing Zimmer Patient specific instruments and Standard instrumentation in people with Osteoarthritis of the Knee, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Zimmer Patient specific instruments and Standard instrumentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2013to 18 Jun 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18-75 years at time of surgery.
- Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the knee.
- Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
- Patients who signed the study consent form prior to surgery.
Who cannot join
- Pregnant women.
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
- Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- Previous knee surgery including those already treated by with a total knee replacement (i.e. requiring a revision knee replacement).
- Muscle contracture around the knee joint
- Individuals with active or suspected infection or sepsis.
- Patients with contraindication to MRI
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Rotherham District General Hospitals NHS Trust
Rotherham, South Yorkshire, S60 2UD
Sheffield Teaching Hospital NHS Trust
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: A Prospective, Randomised Control Trial Assessing Clinical and Radiological Outcomes of Patient Specific Instrumentation In Total Knee Arthroplasty
This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
Read the detailed description
This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The process is similar to traditional knee replacement surgery but approximately 6 weeks prior to the operation patients will undergo an MRI scan of their knee, hip and ankle. From this data the dimensions and rotation of the knee can be accurately measured, and a custom made jig can be made specific to that patients anatomy. The jig is used intra-operatively to make accurate bone cuts according to this pre-operative plan, the type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Zimmer Patient specific instruments, Standard instrumentation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Patient specific instrumentsDevice
A custom made cutting block will be used during total knee replacement surgery. The cutting block is made specific to patient's anatomy based on MRI scans taken 6 weeks prior to surgery.
Standard instrumentationDevice
Standard instrumentation will be used during total knee replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patient specific instrumentation | Experimental | The patient will undergo using patient specific instrumentation Receives: Device: Zimmer Patient specific instruments |
| Standard instrumentation | Active comparator | The patient will undergo surgery using standard instrumentation Receives: Device: Standard instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant alignment
Sagittal and coronal alignment of the knee arthroplasty implant will be measured on full length radiographs
Measured: 6 weeks
Secondary outcomes (1)
Oxford Knee Score
Patient questionnaire
Measured: 1yr, 5yr, 10yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startSep 2013
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Blakey, MBChB, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096393
- Sponsor's protocol ID
- STH16313
- Status last verified
- Jun 2022
- First submitted
- 7 Mar 2014
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Control Trial Assessing Clinical and Radiological Outcomes of Patient Specific Instrumentation In Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02096393
- Acronym / sponsor ID
- STH16313
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 26 Mar 2014 (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 is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
Detailed description
This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The process is similar to traditional knee replacement surgery but approximately 6 weeks prior to the operation patients will undergo an MRI scan of their knee, hip and ankle. From this data the dimensions and rotation of the knee can be accurately measured, and a custom made jig can be made specific to that patients anatomy. The jig is used intra-operatively to make accurate bone cuts according to this pre-operative plan, the type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient specific instrumentation | Experimental | Device: Zimmer Patient specific instrumentsThe patient will undergo using patient specific instrumentation |
| Standard instrumentation | Active comparator | Device: Standard instrumentationThe patient will undergo surgery using standard instrumentation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged 18-75 years at time of surgery.
- Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the knee.
- Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
- Patients who signed the study consent form prior to surgery.
Key exclusion criteria (7 listed)
- Pregnant women.
- Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
- Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
- Previous knee surgery including those already treated by with a total knee replacement (i.e. requiring a revision knee replacement).
- Muscle contracture around the knee joint
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 |
|---|---|---|
| Zimmer Patient specific instrumentsA custom made cutting block will be used during total knee replacement surgery. The cutting block is made specific to patient's anatomy based on MRI scans taken 6 weeks prior to surgery. | Device | Patient specific instrumentation |
| Standard instrumentationStandard instrumentation will be used during total knee replacement surgery. | Device | Standard instrumentation |
Primary outcome
Implant alignment
Time frame: 6 weeks
Sagittal and coronal alignment of the knee arthroplasty implant will be measured on full length radiographs
1 secondary outcome
Oxford Knee Score
Time frame: 1yr, 5yr, 10yr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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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.
Caroline Blakey, MBChB principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer Patient specific instruments and Standard instrumentation in people with Osteoarthritis of the Knee, run by Sheffield Teaching Hospitals NHS Foundation Trust at 2 sites 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: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implant alignment (time frame: 6 weeks). 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 9 Jun 2022.