Arthritis of KneeNCT02581605
Correction of Angular Deformities in Knee Arthrosis
An observational study of Arthritis of Knee, run by Imperial College London at 1 site in United Kingdom.
Trial summary
For participants whose leg bones don't line up properly, extra stress is placed on either the inner or outer side of the knee joint due to uneven transfer of body-weight. Gradually, this extra pressure wears away the smooth cartilage, resulting in osteoarthritis on that side of the knee joint. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arthritis of Knee
- What is being tested?
- Custom-made 'cutting block'
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Osteotomy Arm: Target population: 42 Partial Knee Replacement Arm: Target population: 42
Who may be able to join
- All patients considered suitable candidates for an osteotomy around the knee.
- All patients consenting to an osteotomy around the knee.
- All patients considered medically fit for surgery.
- All patients must be between 18 to 70 years of age.
- All patients considered suitable candidates for a partial knee replacement
- All patients consenting to a partial knee replacement
Show all 12Show fewer
- All patients considered medically fit for surgery Exclusion Criteria
- Patients not suitable for a partial knee replacement.
- Patients who decline surgery.
- Patients lacking capacity to consent.
- Patients under the age of eighteen.
- Patients who do not understand English (written and verbal).
Who cannot join
- Patients not suitable for an osteotomy around the knee.
- Patients with collateral ligament(s) insufficiency.
- Patients who decline surgery.
- Patients lacking capacity to consent.
- Patients who do not understand English (written and verbal).
- Partial Knee Replacement Arm:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Matched Osteotomy to Correct Angular Deformities in Knee Arthrosis
For participants whose leg bones don't line up properly, extra stress is placed on either the inner or outer side of the knee joint due to uneven transfer of body-weight. Gradually, this extra pressure wears away the smooth cartilage, resulting in osteoarthritis on that side of the knee joint. This problem is particularly common in young athletes and places them at risk of early osteoarthritis.
An operation exists whereby one of the bones either side of the knee is cut ( an osteotomy) and hinged open to straighten the leg. This alteration redistributes body-weight more equally across the knee joint and is known to be effective in delaying and possibly preventing, the progression of knee osteoarthritis- especially in younger and physically more active patients in whom a knee replacement is undesirable.
Read more
Currently it is possible to ( accurately) calculate the precise position of the bone cut and number of degrees correction required to straighten a leg using digital x-rays and three-dimensional CT scans. However there is no method of implementing this pre-operative plan during surgery so that the majority of surgeons rely on relatively crude and ipso facto unreliable intra-operative measurements as a guide.
To improve the accuracy of this operation, the investigator propose the use of a custom-made 'cutting block', tailored for each individual patient and its shape will match the contour of the patient's bone to ensure it can only be placed in one position. Pre-cut slots and holes will then guide the saw cut and the number of degrees the bone in hinged open, as per the pre-operative plan; it functions as an intra-operative template for the surgeon.
This study will primarily examine whether there is a close match between the planned and actual correction of leg deformities when using a patient-matched cutting-block.
Read the detailed description
Malalignment of the leg is known to play a significant role in the development of knee arthrosis. Osteotomy can be used to correct angular deformities around the knee. A number of studies have found that the success of this procedure in delaying the progression of knee arthrosis is highly dependent on an accurate of deformity correction.
It is possible to produce a precise pre-operative surgical plan of the osteotomy required for a favourable outcome. However, the majority of surgeons still rely upon relatively crude and ipso facto unreliable intra-operative measurements to guide the actual operation. This is reflected in studies comparing the pre-operative plan with final outcome.
So to facilitate accurate translation of pre-operative osteotomy planning to intra-operative execution, the investigator proposes to transfer two technologies that are already commercially available in arthroplasty into the filed of corrective osteotomy i.e. 3D planning and custom-made patient-matched cutting blocks. This will permit translation of the surgeon's pre-order to ensure precise intra-operative positioning. Once secured slots and holes in the cutting block will ensure that the bony cut and angular correction is performed, and secured with a plate and screws, in the precise location determined by the pre-operative plan.
A prospective multi centre study is proposed, primarily to confirm the efficacy of use, and accuracy of deformity correction around the knee using patient-matched cutting blocks. Accuracy will be assessed by comparing post-operative alignment (measured on plan radiographs and CT scan) with the pre-operative surgical plan. Patient questionnaires to assess outcome will also be collected, and optional gait analysis performed.
- Conditions
- Arthritis of Knee
- Being tested
- Custom-made 'cutting block'
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-made 'cutting block'Device
To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient.
| Study group | Role | What they receive |
|---|---|---|
| Osteotomy Arm | Patients due to undergo an osteotomy around the knee. To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient. Receives: Device: Custom-made 'cutting block' | |
| Partial Knee Replacement Arm | Patients due to undergo a partial knee replacement. To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient. Receives: Device: Custom-made 'cutting block' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final radiographic alignment is with two degrees of pre-operative plan in both coronal and sagittal
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis of KneeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Professor Justin Cobb, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581605
- Sponsor's protocol ID
- 13/LO/1639
- Status last verified
- Mar 2019
- First submitted
- 21 Sep 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Matched Osteotomy to Correct Angular Deformities in Knee Arthrosis
- ClinicalTrials.gov ID
- NCT02581605
- Acronym / sponsor ID
- 13/LO/1639
- Conditions
- Arthritis of Knee
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Oct 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.
For participants whose leg bones don't line up properly, extra stress is placed on either the inner or outer side of the knee joint due to uneven transfer of body-weight. Gradually, this extra pressure wears away the smooth cartilage, resulting in osteoarthritis on that side of the knee joint. This problem is particularly common in young athletes and places them at risk of early osteoarthritis.
An operation exists whereby one of the bones either side of the knee is cut ( an osteotomy) and hinged open to straighten the leg. This alteration redistributes body-weight more equally across the knee joint and is known to be effective in delaying and possibly preventing, the progression of knee osteoarthritis- especially in younger and physically more active patients in whom a knee replacement is undesirable.
Currently it is possible to ( accurately) calculate the precise position of the bone cut and number of degrees correction required to straighten a leg using digital x-rays and three-dimensional CT scans. However there is no method of implementing this pre-operative plan during surgery so that the majority of surgeons rely on relatively crude and ipso facto unreliable intra-operative measurements as a guide.
To improve the accuracy of this operation, the investigator propose the use of a custom-made 'cutting block', tailored for each individual patient and its shape will match the contour of the patient's bone to ensure it can only be placed in one position. Pre-cut slots and holes will then guide the saw cut and the number of degrees the bone in hinged open, as per the pre-operative plan; it functions as an intra-operative template for the surgeon.
This study will primarily examine whether there is a close match between the planned and actual correction of leg deformities when using a patient-matched cutting-block.
Detailed description
Malalignment of the leg is known to play a significant role in the development of knee arthrosis. Osteotomy can be used to correct angular deformities around the knee. A number of studies have found that the success of this procedure in delaying the progression of knee arthrosis is highly dependent on an accurate of deformity correction.
It is possible to produce a precise pre-operative surgical plan of the osteotomy required for a favourable outcome. However, the majority of surgeons still rely upon relatively crude and ipso facto unreliable intra-operative measurements to guide the actual operation. This is reflected in studies comparing the pre-operative plan with final outcome.
So to facilitate accurate translation of pre-operative osteotomy planning to intra-operative execution, the investigator proposes to transfer two technologies that are already commercially available in arthroplasty into the filed of corrective osteotomy i.e. 3D planning and custom-made patient-matched cutting blocks. This will permit translation of the surgeon's pre-order to ensure precise intra-operative positioning. Once secured slots and holes in the cutting block will ensure that the bony cut and angular correction is performed, and secured with a plate and screws, in the precise location determined by the pre-operative plan.
A prospective multi centre study is proposed, primarily to confirm the efficacy of use, and accuracy of deformity correction around the knee using patient-matched cutting blocks. Accuracy will be assessed by comparing post-operative alignment (measured on plan radiographs and CT scan) with the pre-operative surgical plan. Patient questionnaires to assess outcome will also be collected, and optional gait analysis performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteotomy Arm | – | Device: Custom-made 'cutting block'Patients due to undergo an osteotomy around the knee. To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient. |
| Partial Knee Replacement Arm | – | Device: Custom-made 'cutting block'Patients due to undergo a partial knee replacement. To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Osteotomy Arm: Target population: 42 Partial Knee Replacement Arm: Target population: 42
Key inclusion criteria (12 listed)
- All patients considered suitable candidates for an osteotomy around the knee.
- All patients consenting to an osteotomy around the knee.
- All patients considered medically fit for surgery.
- All patients must be between 18 to 70 years of age.
- All patients considered suitable candidates for a partial knee replacement
Key exclusion criteria (6 listed)
- Patients not suitable for an osteotomy around the knee.
- Patients with collateral ligament(s) insufficiency.
- Patients who decline surgery.
- Patients lacking capacity to consent.
- Patients who do not understand English (written and verbal).
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 |
|---|---|---|
| Custom-made 'cutting block'To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient. | Device | Osteotomy Arm, Partial Knee Replacement Arm |
Primary outcome
Final radiographic alignment is with two degrees of pre-operative plan in both coronal and sagittal
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Professor Justin Cobb principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis of Knee, run by Imperial College London 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 12 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
Final radiographic alignment is with two degrees of pre-operative plan in both coronal and sagittal (time frame: 24 months). 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 13 Mar 2019.