Knee PathologyNCT04364334
Knee Registry (Knieregister)
An observational study of Knee Pathology and Osteoarthritis, Knee, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Rationale: In view of patient care, patient characteristics and treatment parameters are registered for all patients visiting the Mobility Clinic of the University Medical Center Utrecht for orthopaedic knee treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Pathology, Osteoarthritis, Knee, Osteochondritis Dissecans
- How many people
- 1,000,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2017to Jan 2100
- How long will I take part?
- 20 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that visit the Mobility Clinic at the UMC Utrecht for their knee pathology.
Who may be able to join
- Receives orthopaedic knee surgery or conservative knee treatment (advice, physiotherapy, injections etc) at the UMC Utrecht;
- Able to read and understand Dutch language;
- Is able and willing to signs the broad consent form.
Who cannot join
- Receives no treatment (refusal of surgery or treatment);
- Receives treatment elsewhere.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3584 CX
Roel Custers, Dr, 0887558327 ext. +31, r.j.h.custers@umcutrecht.nl
About this study
Official title: Collecting Diagnostic, Treatment and Follow-up Data on Knee Treatments.
Rationale: In view of patient care, patient characteristics and treatment parameters are registered for all patients visiting the Mobility Clinic of the University Medical Center Utrecht for orthopaedic knee treatment. Patients also fill out questionnaires for function, pain and mobility of the knee, before and after treatment.
Objective: The main objective of this registry is to collect patient characteristics and treatment parameters together with data from the questionnaires in a database. This knee registry can be used for future research questions.
Read more
Study design: This is a longitudinal observational registry.
Study population: All patients that visit the Mobility Clinic will be asked to participate in the knee registry. Patients that meet one or more of the following criteria will be excluded: are below the age of 16, not able or willing to sign the broad consent form, not being able to read and understand Dutch language, or receiving medical treatment for their knee elsewhere.
Main study parameters/endpoints: Data will be collected for future research for which the purpose is not known at this time. When new research will be conducted, study parameters will be set. A study application has to be submitted to the institutional ethical review board of the University Medical Center Utrecht. Patients do not need to be asked permission for the use of their data for each study individually. Only when additional information is needed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for patients to participate in this registry is minimal and consists of time. Any future results may be beneficial for patients. Participation or refusal to participate in the registry has no consequences for their treatment.
- Conditions
- Knee Pathology, Osteoarthritis, Knee, Osteochondritis Dissecans, Chondral Defect, Osteochondral Defect
- Keywords
- Knee
- Medical subject headings
- Osteoarthritis, Knee, Osteochondritis Dissecans
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 |
|---|---|---|
| Knee registry patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics and medical data
General patient characteristics, medical data, and specific knee data.
Measured: Status at baseline.
Change in EQ5D (EuroQol 5 dimensions)
The EQ-5D-5L is a questionnaire about the quality of life on a scale of 0-100 and has 5 dimensions, each dimension has 5 levels. A higher score indicates a higher health utility. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)
Questionnaire for evaluating limitations and symptoms for patients with knee complaints. Scale of 0-100, where 100 indicates no symptoms and limitations and 0 an extreme amount of symptoms and limitations.
Measured: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Change in IKDC (International Knee Documentation Committee)
Questionnaire about symptoms and function for patients with knee complaints. Scale of 0-100 where 100 indicates the highest level of function and lowest level of symptoms.
Measured: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Change in SF-36
Questionnaire about the health related quality of life. There are several subcategories on a scale of 0-100, where a higher score indicates a better health related quality of life.
Measured: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Change in VAS pain (Visual Analogue Scale)
Question about pain on on a horizontal visual analogue scale, where the endpoints are labelled 'no pain' and 'unbearable pain'. This is converted into a scale of 0-100 where a higher score indicates a higher level of pain.
Measured: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Change in NRS pain (Numeric Rating Scale)
Question about the pain on a scale of 0 to 10 during rest and activity. 0 indicating no pain, 10 indicating extreme pain.
Measured: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Change in Tegner
Question about the level of work and sports activity on a scale from 0 to 10, where 10 indicates a high level of activity.
Measured: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Anker questions
Questions about the results of surgery for functionality, pain and satifaction. Descriptive.
Measured: After treatment at 3, 6 and 12 months
Change in OKS (Oxford knee score)
Questionnaire about the pain and limitations of activities for patients with a knee prosthesis. Maximal total score is 60, indicating the maximum level of pain or functional limitations.
Measured: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Change in healthcare use and costs
iMTA-questionnaire descriptive (Medical Consumption and Productivity Cost Questionnaire)
Measured: Before treatment, and after treatment at 6, 9 (only for ACI patients) and 12 months.
Change in KOOS-PS (Knee Injury and Osteoarthritis Outcome Score-short form)
Short form of the questionnaire for evaluating limitations and symptoms for patients with knee complaints. Scale of 0-100, where 100 indicates no symptoms and limitations and 0 an extreme amount of symptoms and limitations.
Measured: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study startJan 2017
- Primary completionJan 2100 (estimated)
- Study completionJan 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee PathologyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.J.H. Custers, UMC Utrecht
- Investigators
- Roel Custers, Dr, Principal investigator, Orthopedic surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364334
- Sponsor's protocol ID
- 17-005
- Status last verified
- Nov 2023
- First submitted
- 15 Apr 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: New research questions that requires data from the registry need to be discussed and approved by the PI and data manager/coordinator of this registry. The proposal should also be in agreement with the research collaboration and data transfer guidelines and agreements of the UMC Utrecht. Proposals need to be submitted to the institutional ethical review board of the University Medical Center Utrecht. After review, the data selection will be provided to the researcher.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecting Diagnostic, Treatment and Follow-up Data on Knee Treatments.
- ClinicalTrials.gov ID
- NCT04364334
- Acronym / sponsor ID
- 17-005
- Conditions
- Knee Pathology, Osteoarthritis, Knee, Osteochondritis Dissecans, Chondral Defect, Osteochondral Defect
- Keywords
- Knee
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2100 (estimated)
- Study completion
- Jan 2100 (estimated)
- First posted
- 28 Apr 2020 (actual)
- 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.
Rationale: In view of patient care, patient characteristics and treatment parameters are registered for all patients visiting the Mobility Clinic of the University Medical Center Utrecht for orthopaedic knee treatment. Patients also fill out questionnaires for function, pain and mobility of the knee, before and after treatment.
Objective: The main objective of this registry is to collect patient characteristics and treatment parameters together with data from the questionnaires in a database. This knee registry can be used for future research questions.
Study design: This is a longitudinal observational registry.
Study population: All patients that visit the Mobility Clinic will be asked to participate in the knee registry. Patients that meet one or more of the following criteria will be excluded: are below the age of 16, not able or willing to sign the broad consent form, not being able to read and understand Dutch language, or receiving medical treatment for their knee elsewhere.
Main study parameters/endpoints: Data will be collected for future research for which the purpose is not known at this time. When new research will be conducted, study parameters will be set. A study application has to be submitted to the institutional ethical review board of the University Medical Center Utrecht. Patients do not need to be asked permission for the use of their data for each study individually. Only when additional information is needed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for patients to participate in this registry is minimal and consists of time. Any future results may be beneficial for patients. Participation or refusal to participate in the registry has no consequences for their treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee registry patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that visit the Mobility Clinic at the UMC Utrecht for their knee pathology.
Key inclusion criteria (3 listed)
- Receives orthopaedic knee surgery or conservative knee treatment (advice, physiotherapy, injections etc) at the UMC Utrecht;
- Able to read and understand Dutch language;
- Is able and willing to signs the broad consent form.
Key exclusion criteria (2 listed)
- Receives no treatment (refusal of surgery or treatment);
- Receives treatment elsewhere.
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
Patient characteristics and medical data
Time frame: Status at baseline.
General patient characteristics, medical data, and specific knee data.
Change in EQ5D (EuroQol 5 dimensions)
Time frame: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
The EQ-5D-5L is a questionnaire about the quality of life on a scale of 0-100 and has 5 dimensions, each dimension has 5 levels. A higher score indicates a higher health utility. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Questionnaire for evaluating limitations and symptoms for patients with knee complaints. Scale of 0-100, where 100 indicates no symptoms and limitations and 0 an extreme amount of symptoms and limitations.
Change in IKDC (International Knee Documentation Committee)
Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Questionnaire about symptoms and function for patients with knee complaints. Scale of 0-100 where 100 indicates the highest level of function and lowest level of symptoms.
Change in SF-36
Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Questionnaire about the health related quality of life. There are several subcategories on a scale of 0-100, where a higher score indicates a better health related quality of life.
Change in VAS pain (Visual Analogue Scale)
Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Question about pain on on a horizontal visual analogue scale, where the endpoints are labelled 'no pain' and 'unbearable pain'. This is converted into a scale of 0-100 where a higher score indicates a higher level of pain.
Change in NRS pain (Numeric Rating Scale)
Time frame: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Question about the pain on a scale of 0 to 10 during rest and activity. 0 indicating no pain, 10 indicating extreme pain.
Change in Tegner
Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Question about the level of work and sports activity on a scale from 0 to 10, where 10 indicates a high level of activity.
Anker questions
Time frame: After treatment at 3, 6 and 12 months
Questions about the results of surgery for functionality, pain and satifaction. Descriptive.
Change in OKS (Oxford knee score)
Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Questionnaire about the pain and limitations of activities for patients with a knee prosthesis. Maximal total score is 60, indicating the maximum level of pain or functional limitations.
Change in healthcare use and costs
Time frame: Before treatment, and after treatment at 6, 9 (only for ACI patients) and 12 months.
iMTA-questionnaire descriptive (Medical Consumption and Productivity Cost Questionnaire)
Change in KOOS-PS (Knee Injury and Osteoarthritis Outcome Score-short form)
Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Short form of the questionnaire for evaluating limitations and symptoms for patients with knee complaints. Scale of 0-100, where 100 indicates no symptoms and limitations and 0 an extreme amount of symptoms and limitations.
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 5 Dec 2023.
- Het knieregister: register voor kniebehandelingenLink provided by the sponsor.
- Knee joint distraction in regular care for treatment of knee osteoarthritis: A comparison with clinical trial data.Link provided by the sponsor.
- ICRS Patient RegistryLink provided by the sponsor.
- Reduction of pin tract infections during external fixation using cadexomer iodineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. New research questions that requires data from the registry need to be discussed and approved by the PI and data manager/coordinator of this registry. The proposal should also be in agreement with the research collaboration and data transfer guidelines and agreements of the UMC Utrecht. Proposals need to be submitted to the institutional ethical review board of the University Medical Center Utrecht. After review, the data selection will be provided to the researcher.
Related trials for Knee Pathology
Recruiting
A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
Pain (Knee), Pain and Anxiety
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
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.
Roel Custers, Dr principal investigator
Orthopedic surgeon
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 Knee Pathology and Osteoarthritis, 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Dec 2023. 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?
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?
Contact Linda Kornegoor, MSc (088 75 69349 ext. +31, l.kornegoor@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient characteristics and medical data (time frame: Status at baseline.). The study lists 12 primary outcomes in all. 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 5 Dec 2023.