Medial Compartment Osteoarthritis of the KneeNCT01269944
Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging
An observational study of Medial Compartment Osteoarthritis of the Knee, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Medial compartment osteoarthritis of the knee is commonly treated by a surgical intervention called 'high tibial osteotomy' (VTO). Although it has repeatedly been shown that pain improves following this procedure, it is unknown how cartilage quality is affected by the procedure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Medial Compartment Osteoarthritis of the Knee
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2007to Feb 2011
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients above 18 years with osteoarthritis of the knee and a future planned osteotomy of the tibia or femur are eligible for participation in this study.
Who may be able to join
- Ten patients will be included satisfying the following inclusion criteria:
- Both males and females
- Patients >18 years old
- Indication as set by treating physician for operative procedure around the knee: HTO (high tibial osteotomy), femoral osteotomy
- Patient informed consent signed Note: Patients with previous surgery, history of intra-articular medication, meniscectomy or ACL lesions can be included in this study.
Who cannot join
- The following patients are excluded from participating in this study:
- Known anaphylactic reactions to Gadolinium or related substances
- Kidney diseases with a creatinin excretion of < 20 ml/min
- Risk groups for MRI scanning due to magnetic field or contrast agent (9, 10): Metal in body: Pacemaker / AICD / ICD (coronary defibrillator), Nervus vagus (X) stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insuline pump, Metal implants; f/e screws, prostheses, piercings.
- Claustrofibia
- First three months of pregnancy (not sufficient information available about effects of contrast agent on foetal development in this stage). Patients will be asked if they may be pregnant (< 3 months of pregnancy): if uncertain, they will be excluded.
- Contra-indications for MRI scanning, as well as contra-indications to intra-venous administration of contrast agents were discussed with Ms. Shanta Kalaykhan-Sewradj, head of MRI technicians in the UMC Utrecht. For further information, the booklet 'Bijwerkingen van contrastmiddelen: de gadoliniumverbindingen' by Esther Ensing and Janet Hoven was used (Published by Nederlandse Vereniging voor Slachtoffers van Medische Contrastmiddelen, 2004).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging, a Pilot Study
Medial compartment osteoarthritis of the knee is commonly treated by a surgical intervention called 'high tibial osteotomy' (VTO). Although it has repeatedly been shown that pain improves following this procedure, it is unknown how cartilage quality is affected by the procedure. In this study, a recently developed MRI technique is used to evaluate changes in cartilage quality before and after the surgery. Changes in MRI signals are correlated to subjective improvements (score lists). 10 patients participate in this study. Approval has been granted by the Medical Ethical Committee of the University Medical Center Utrecht. All participants are required to give informed consent before participation.
Read the detailed description
Rationale: Medial compartment osteoarthritis (OA) of the knee is an invalidating disorder and leads to pain, decreased range of motion and inactivity. Two procedures aiming at maintaining original cartilage are the high tibial osteotomy (HTO) and the femur osteotomy. However, effects of this procedure on cartilage quality are not known.
Recently, a new technique has been developed which enables analysing changes in cartilage composition in vivo: the dGEMRIC. The dGEMRIC-technique is based on binding of negatively charged contrast agent Gadolinium (Gd(DPTA)2) to the glycosaminoglycans in the knee cartilage. The T1-signal reflects the gadolinium uptake by the proteoglycans of the knee and thus provides us with an indicative parameter of the cartilage quality. Visualising changes in cartilage composition enables better pre-operative patient selection as well as optimal timing of the operative procedure.
Objective: Primary objective: Evaluate changes in cartilage glycosaminoglycan content using dGEMRIC, in patients with osteoarthritis of the knee undergoing axial correction (HTO, femur osteotomy). Secondary objective: Correlate quantitative MRI data to subjective symptom scores (KOOS, WOMAC, VAS, Knee Society Score)
Study design: This study is a prospective observational study.
Study population: Ten patients will be included satisfying the following inclusion criteria:
- Both males and females older than 18 years
- Indication as set by treating physician for operative procedure around the knee: HTO (high tibial osteotomy), femoral osteotomy
Main study parameters/endpoints: In addition to their regular treatment, patients will receive an MRI scan with dGEMRIC settings before and 9 months after the surgical procedure, after removal of orthopaedic hardware. They will further receive questionnaires (VAS, WOMAC, KOOS, Knee Society Scale) before the surgical procedure and at 6,12, and 24 months after the surgical procedure.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to their regular treatment, patients participating in this study will undergo two MRI scans of their knee. Performing of these scans will take about 4 hours. Further, orthopaedic hardware will be removed in daycare before the second MRI (burden: 1 day). Patients are asked to fill out questionnaires before- and after their surgical treatment. Filling out these questionnaires will take around 20 minutes per time moment (4 in total). Risks associated with the MRI scan are the very infrequently occurring allergic reactions to the contrast agent, which is used to depict the cartilage. Risks associated with removal of orthopaedic hardware at 9 months and not different than removal of hardware at a later stage: infection, bleeding, allergic reaction, dental damage or paresthesias.
- Keywords
- osteoarthritis, knee, high wedge tibial osteotomy, dGEMRIC
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Medial compartment knee osteoarthritis | Patients with medial compartment osteoarthritis of the knee, as proven by x-rays and clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI T1 signal, change from baseline
MRI T1 signal is deducted from dGEMRIC measurements
Measured: Change from baseline 9 months after surgery (HTO)
Secondary outcomes (1)
KOOS clinical score, change from baseline
Knee and Osteoarthritis Outcome Score (clinical score, completed by all participants)
Measured: Change from baseline 9 months after surgery (HTO)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJul 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medial Compartment Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.B.F. Saris, UMC Utrecht
- Investigators
- Daniel B Saris, MD, PhD, Study chair, University Medical Center Utrecht, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269944
- Sponsor's protocol ID
- dGEMRIC HTO
- Status last verified
- Nov 2017
- First submitted
- 29 Dec 2010
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burstein D. Tracking longitudinal changes in knee degeneration and repair. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:51-3. doi: 10.2106/JBJS.H.01412.
PubMed 19182025Brouwer RW, Bierma-Zeinstra SM, van Koeveringe AJ, Verhaar JA. Patellar height and the inclination of the tibial plateau after high tibial osteotomy. The open versus the closed-wedge technique. J Bone Joint Surg Br. 2005 Sep;87(9):1227-32. doi: 10.1302/0301-620X.87B9.15972.
PubMed 16129748Rutgers M, Bartels LW, Tsuchida AI, Castelein RM, Dhert WJ, Vincken KL, van Heerwaarden RJ, Saris DB. dGEMRIC as a tool for measuring changes in cartilage quality following high tibial osteotomy: a feasibility study. Osteoarthritis Cartilage. 2012 Oct;20(10):1134-41. doi: 10.1016/j.joca.2012.07.001. Epub 2012 Jul 10.
PubMed 22796509
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging, a Pilot Study
- ClinicalTrials.gov ID
- NCT01269944
- Acronym / sponsor ID
- dGEMRIC HTO
- Keywords
- osteoarthritis, knee, high wedge tibial osteotomy, dGEMRIC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 Jan 2011 (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.
Medial compartment osteoarthritis of the knee is commonly treated by a surgical intervention called 'high tibial osteotomy' (VTO). Although it has repeatedly been shown that pain improves following this procedure, it is unknown how cartilage quality is affected by the procedure. In this study, a recently developed MRI technique is used to evaluate changes in cartilage quality before and after the surgery. Changes in MRI signals are correlated to subjective improvements (score lists). 10 patients participate in this study. Approval has been granted by the Medical Ethical Committee of the University Medical Center Utrecht. All participants are required to give informed consent before participation.
Detailed description
Rationale: Medial compartment osteoarthritis (OA) of the knee is an invalidating disorder and leads to pain, decreased range of motion and inactivity. Two procedures aiming at maintaining original cartilage are the high tibial osteotomy (HTO) and the femur osteotomy. However, effects of this procedure on cartilage quality are not known.
Recently, a new technique has been developed which enables analysing changes in cartilage composition in vivo: the dGEMRIC. The dGEMRIC-technique is based on binding of negatively charged contrast agent Gadolinium (Gd(DPTA)2) to the glycosaminoglycans in the knee cartilage. The T1-signal reflects the gadolinium uptake by the proteoglycans of the knee and thus provides us with an indicative parameter of the cartilage quality. Visualising changes in cartilage composition enables better pre-operative patient selection as well as optimal timing of the operative procedure.
Objective: Primary objective: Evaluate changes in cartilage glycosaminoglycan content using dGEMRIC, in patients with osteoarthritis of the knee undergoing axial correction (HTO, femur osteotomy). Secondary objective: Correlate quantitative MRI data to subjective symptom scores (KOOS, WOMAC, VAS, Knee Society Score)
Study design: This study is a prospective observational study.
Study population: Ten patients will be included satisfying the following inclusion criteria:
- Both males and females older than 18 years
- Indication as set by treating physician for operative procedure around the knee: HTO (high tibial osteotomy), femoral osteotomy
Main study parameters/endpoints: In addition to their regular treatment, patients will receive an MRI scan with dGEMRIC settings before and 9 months after the surgical procedure, after removal of orthopaedic hardware. They will further receive questionnaires (VAS, WOMAC, KOOS, Knee Society Scale) before the surgical procedure and at 6,12, and 24 months after the surgical procedure.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to their regular treatment, patients participating in this study will undergo two MRI scans of their knee. Performing of these scans will take about 4 hours. Further, orthopaedic hardware will be removed in daycare before the second MRI (burden: 1 day). Patients are asked to fill out questionnaires before- and after their surgical treatment. Filling out these questionnaires will take around 20 minutes per time moment (4 in total). Risks associated with the MRI scan are the very infrequently occurring allergic reactions to the contrast agent, which is used to depict the cartilage. Risks associated with removal of orthopaedic hardware at 9 months and not different than removal of hardware at a later stage: infection, bleeding, allergic reaction, dental damage or paresthesias.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medial compartment knee osteoarthritis | – | –Patients with medial compartment osteoarthritis of the knee, as proven by x-rays and clinical examination |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients above 18 years with osteoarthritis of the knee and a future planned osteotomy of the tibia or femur are eligible for participation in this study.
Key inclusion criteria (5 listed)
- Both males and females
- Patients >18 years old
- Indication as set by treating physician for operative procedure around the knee: HTO (high tibial osteotomy), femoral osteotomy
- Patient informed consent signed Note: Patients with previous surgery, history of intra-articular medication, meniscectomy or ACL lesions can be included in this study.
Key exclusion criteria (7 listed)
- The following patients are excluded from participating in this study:
- Known anaphylactic reactions to Gadolinium or related substances
- Kidney diseases with a creatinin excretion of < 20 ml/min
- Risk groups for MRI scanning due to magnetic field or contrast agent (9, 10): Metal in body: Pacemaker / AICD / ICD (coronary defibrillator), Nervus vagus (X) stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insuline pump, Metal implants; f/e screws, prostheses, piercings.
- Claustrofibia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRI T1 signal, change from baseline
Time frame: Change from baseline 9 months after surgery (HTO)
MRI T1 signal is deducted from dGEMRIC measurements
1 secondary outcome
KOOS clinical score, change from baseline
Time frame: Change from baseline 9 months after surgery (HTO)
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 6 Nov 2017.
- Background: PubMed 19182025Burstein D. Tracking longitudinal changes in knee degeneration and repair. J Bone Joint Surg Am. 2009 Feb;91 Suppl 1:51-3. doi: 10.2106/JBJS.H.01412.
- Background: PubMed 16129748Brouwer RW, Bierma-Zeinstra SM, van Koeveringe AJ, Verhaar JA. Patellar height and the inclination of the tibial plateau after high tibial osteotomy. The open versus the closed-wedge technique. J Bone Joint Surg Br. 2005 Sep;87(9):1227-32. doi: 10.1302/0301-620X.87B9.15972.
- Derived from this study: PubMed 22796509Rutgers M, Bartels LW, Tsuchida AI, Castelein RM, Dhert WJ, Vincken KL, van Heerwaarden RJ, Saris DB. dGEMRIC as a tool for measuring changes in cartilage quality following high tibial osteotomy: a feasibility study. Osteoarthritis Cartilage. 2012 Oct;20(10):1134-41. doi: 10.1016/j.joca.2012.07.001. Epub 2012 Jul 10.
- Affiliation siteLink provided by the sponsor.
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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.
Daniel B Saris, MD, PhD study chair
University Medical Center Utrecht, the Netherlands
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 Medial Compartment Osteoarthritis of the Knee, run by UMC Utrecht at 1 site in Netherlands.
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 5 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 6 Nov 2017. 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 Netherlands. 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?
MRI T1 signal, change from baseline (time frame: Change from baseline 9 months after surgery (HTO)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01269944, which also lists 3 linked publications.
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 6 Nov 2017.