Osteoarthritis, KneeNCT03067090
Aquamid Reconstruction for Osteoarthritis of the Knee
A study testing Aquamid Reconstruction in people with Osteoarthritis, Knee, run by A2 Reumatologi Og Idrætsmedicin at 1 site in Denmark.
Trial summary
Osteoarthritis (OA) causes degradation and deformities of joints, including knees, hips, hands, and feet. Approximately more than 55% of populations above 45 years and more than 70% of population above 70 years will develop OA in at least one joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Aquamid Reconstruction
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Apr 2017to 15 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- WOMAC pain score >/= 5
- Kellgren and Lawrence radiographic scoring >/= 1
- Signed informed consent form
Who cannot join
- Other diseases affecting the joints such as rheumatoid arthritis
- Actual or recurrent infections requiring intravenous antibiotic treatment within the last 30 days or oral antibiotic treatment within the last 14 days before inclusion
- Less than 12 weeks since injection of HA or corticosteroids in study-knee joint before treatment
- Pregnancy or lactation
- Not able to comply with the requirements of the study
- Previous alloplasty
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
A2 reumatologi og idrætsmedicin
Hillerød, 3400
Peter A Hartkopp, MD PhD, +4548200530, ah@a2privathospital.dk
About this study
Official title: Prospective Study of Aquamid Reconstruction in Patients With Osteoarthritis of the Knee
Osteoarthritis (OA) causes degradation and deformities of joints, including knees, hips, hands, and feet. Approximately more than 55% of populations above 45 years and more than 70% of population above 70 years will develop OA in at least one joint. The symptoms are dominated by pain but also stiffness and swelling occur. There is currently no cure for OA, and the ultimate treatment is joint replacement surgery. However, there is an unmet need to identify other treatment options that may delay or avoid surgery.
Aquamid Reconstruction (AR) is a polyacrylamide hydrogel (PAAG) which is a non-degradable, highly visco-elastic synthetic gel, which is atoxic with durable effect and tissue-compatibility and well tolerated by mammal tissue by allowing in vivo vessel and fibrous in-growth. Experimental studies supported by histopathological observations have shown that AR exerts its effect via integration over time within the soft tissues, through a combination of vessel in-growth and molecular water exchange. Intra-articular injection of AR is expected to provide permanent pain relief and improve the functional ability through a cushioning or padding effect on the joint and thereby reduce symptoms and improve patients' quality of life.
The purpose of this study is to obtain information of the safety and effectiveness of AR in patients with OA of the knee.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Aquamid Reconstruction
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquamid ReconstructionDevice
AR contains 2.5% polyacrylamide and 97.5% non-pyrogenic water, with a unique molecular structure that allows the normal water exchange with the surrounding tissue without losing shape or effect. AR is biocompatible, non-biodegradable, stable and sterile.
The gel is provided in a sterile, pre-filled 1 ml sealed syringe. The gel is intended to be injected intra-articularly with a sterile 21G x 2 inch (0.8 x 50 mm) needle.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Aquamid Reconstruction | Experimental | Intra-articular injection of 3 ml aquamid reconstruction (AR) to the knee. A second injection of 3 ml will take place after 1 month (+/- 2 weeks). Receives: Device: Aquamid Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the pain subscore of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC is a patient reported questionnaire that is easy to use and evaluates three domains; pain (five questions), stiffness (two questions) and physical function (17 questions), each weighted on a similar computation. The WOMAC Index is sensitive to change and is valid for elderly subjects with knee OA.
Measured: 6 months
Secondary outcomes (2)
Change from baseline in all subscores of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC is a patient reported questionnaire that is easy to use and evaluates three domains; pain (five questions), stiffness (two questions) and physical function (17 questions), each weighted on a similar computation. The WOMAC Index is sensitive to change and is valid for elderly subjects with knee OA.
Measured: 3, 6 and 12 months
Participants' percieved effect
Participants will be surveyed about the current state of the treated knee. Predefined answers are: Worsened; No change; Improved; Cured.
Measured: 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start21 Apr 2017
- Primary completion15 Sep 2018 (estimated)
- Study completion15 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A2 Reumatologi Og Idrætsmedicin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Hartkopp, Principal investigator, A2 Reumatologi of idrætsmedicin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067090
- Sponsor's protocol ID
- A2-001
- Status last verified
- Jun 2018
- First submitted
- 24 Feb 2017
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Aquamid Reconstruction in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03067090
- Acronym / sponsor ID
- A2-001
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- A2 Reumatologi Og IdrætsmedicinUniversity, hospital or other
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 15 Sep 2018 (estimated)
- Study completion
- 15 Mar 2019 (estimated)
- First posted
- 1 Mar 2017 (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.
Osteoarthritis (OA) causes degradation and deformities of joints, including knees, hips, hands, and feet. Approximately more than 55% of populations above 45 years and more than 70% of population above 70 years will develop OA in at least one joint. The symptoms are dominated by pain but also stiffness and swelling occur. There is currently no cure for OA, and the ultimate treatment is joint replacement surgery. However, there is an unmet need to identify other treatment options that may delay or avoid surgery.
Aquamid Reconstruction (AR) is a polyacrylamide hydrogel (PAAG) which is a non-degradable, highly visco-elastic synthetic gel, which is atoxic with durable effect and tissue-compatibility and well tolerated by mammal tissue by allowing in vivo vessel and fibrous in-growth. Experimental studies supported by histopathological observations have shown that AR exerts its effect via integration over time within the soft tissues, through a combination of vessel in-growth and molecular water exchange. Intra-articular injection of AR is expected to provide permanent pain relief and improve the functional ability through a cushioning or padding effect on the joint and thereby reduce symptoms and improve patients' quality of life.
The purpose of this study is to obtain information of the safety and effectiveness of AR in patients with OA of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Aquamid Reconstruction | Experimental | Device: Aquamid ReconstructionIntra-articular injection of 3 ml aquamid reconstruction (AR) to the knee. A second injection of 3 ml will take place after 1 month (+/- 2 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- WOMAC pain score >/= 5
- Kellgren and Lawrence radiographic scoring >/= 1
- Signed informed consent form
Key exclusion criteria (6 listed)
- Other diseases affecting the joints such as rheumatoid arthritis
- Actual or recurrent infections requiring intravenous antibiotic treatment within the last 30 days or oral antibiotic treatment within the last 14 days before inclusion
- Less than 12 weeks since injection of HA or corticosteroids in study-knee joint before treatment
- Pregnancy or lactation
- Not able to comply with the requirements of the study
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 |
|---|---|---|
| Aquamid ReconstructionAR contains 2.5% polyacrylamide and 97.5% non-pyrogenic water, with a unique molecular structure that allows the normal water exchange with the surrounding tissue without losing shape or effect. AR is biocompatible, non-biodegradable, stable and sterile. The gel is provided in a sterile, pre-filled 1 ml sealed syringe. The gel is intended to be injected intra-articularly with a sterile 21G x 2 inch (0.8 x 50 mm) needle. | Device | Intra-articular Aquamid Reconstruction |
Primary outcome
Change from baseline in the pain subscore of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 6 months
The WOMAC is a patient reported questionnaire that is easy to use and evaluates three domains; pain (five questions), stiffness (two questions) and physical function (17 questions), each weighted on a similar computation. The WOMAC Index is sensitive to change and is valid for elderly subjects with knee OA.
2 secondary outcomes
Change from baseline in all subscores of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 3, 6 and 12 months
Participants' percieved effect
Time frame: 1, 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Andreas Hartkopp principal investigator
A2 Reumatologi of idrætsmedicin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquamid Reconstruction in people with Osteoarthritis, Knee, run by A2 Reumatologi Og Idrætsmedicin at 1 site in Denmark.
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 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: status not confirmed, as of the sponsor's last update on 20 Jun 2018. 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 Denmark. 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?
Contact Andreas Hartkopp, MD, PhD (+45 48200530, ah@a2privathospital.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the pain subscore of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: 6 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 20 Jun 2018.