Osteoarthritis, KneePhase 2KITNCT02776514
Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis
A Phase 2 study testing Triamcort, Platelet-rich-plasma and Suplasyn1 in people with Osteoarthritis, Knee, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
This study investigates clinical outcome and imaging outcome parameters after intraarticular injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients with early osteoarthritis of the knee 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?
- Triamcort, Platelet-rich-plasma and Suplasyn1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2016to Nov 2020
- Phase
- Phase 2
- 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
- gonarthritis Kellgren 1,2,3 with symptoms
- german speaking
- informed consent
Who cannot join
- -age under 18, gonarthritis, Kellgren 4, anticoagulation therapy, known inflammatory disease or infection, cardiovascular disease NYHA IV, immunosuppression, contraindication for MRI, pregnancy, no informed consent, NSAR 3 days before injection, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraarticular Injections of Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis
This study investigates clinical outcome and imaging outcome parameters after intraarticular injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients with early osteoarthritis of the knee joint.
Read the detailed description
Osteoarthritis of the knee joint is a very common disease in middle aged and elderly patients. This study evaluates the efficiency of different commonly used substances for intraarticular, non-operative treatment in early stages of this disease.
120 patients receive an fluoroscopic guided injection in the knee joint: 30 patients get injection with steroids 30 patients get injection with prp 30 patients get injection with hyaluronic acid 30 patients get injection with placebo (iopamiro contrast media)
Primary outcome: - clinical outcome (pain using numeric rating scale)
- Magnetic Resonance imaging (cartilage defects etc.)
- Conditions
- Osteoarthritis, Knee
- Being tested
- Triamcort, Platelet-rich-plasma, Suplasyn1, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcortDrug
Fluoroscopic guided injection in the knee joint
Platelet-rich-plasmaDrug
Suplasyn1Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Triamcort (1 ml, 40 mg/ml) | Active comparator | 30 patients receive intraarticular injection with steroids (and contrast media Iopamiro 200) Receives: Drug: Triamcort |
| Platelet-rich-plasma (PRP 3 ml) | Active comparator | 30 patients receive intraarticular injection with platelet-rich-plasma (PRP) (and contrast media Iopamiro 200) Receives: Drug: Platelet-rich-plasma |
| Suplasyn1-shot (60 mg/ ml) | Active comparator | 30 patients receive intraarticular injection with hyaluronic acid (and contrast media Iopamiro 200) Receives: Drug: Suplasyn1 |
| Placebo (Iopamiro 200) | Placebo comparator | 30 patients receive intraarticular injection with contrast media only Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
numeric rating scale (NRS) and WOMAC
Measured: up to 24 months after injection
Magnetic Resonance imaging
cartilage volume (ml)
Measured: up to 12 months after injection
Magnetic Resonance imaging
T2-values in cartilage (mean Signal +/- Standard Deviation) in subregions
Measured: up to 12 months after injection
Secondary outcomes (3)
WOMAC score (stiffness, difficulty)
Clinical outcome
Measured: up to 24 months after injection
Tegner Activity Scale
Clinical outcome
Measured: up to 24 months after injection
Knee mobility and thigh circumference
Clinical assessment, comparison to baseline
Measured: 3 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftung für Rheumaforschung Zurich, Stiftung Marie-Lou Ringgenberg Bern
- Responsible party
- Sponsor
- Investigators
- Andrea B Rosskopf, MD, Principal investigator, Radiology University Hospital Balgrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776514
- Sponsor's protocol ID
- W-560
- Acronym
- KIT
- Status last verified
- Jan 2022
- First submitted
- 18 Feb 2016
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tschopp M, Pfirrmann CWA, Brunner F, Fucentese SF, Galley J, Stern C, Sutter R, Catanzaro S, Kuhne N, Rosskopf AB. Morphological and Quantitative Parametric MRI Follow-up of Cartilage Changes Before and After Intra-articular Injection Therapy in Patients With Mild to Moderate Knee Osteoarthritis: A Randomized, Placebo-Controlled Trial. Invest Radiol. 2024 Sep 1;59(9):646-655. doi: 10.1097/RLI.0000000000001067. Epub 2024 Feb 28.
PubMed 38421679Tschopp M, Pfirrmann CWA, Fucentese SF, Brunner F, Catanzaro S, Kuhne N, Zwyssig I, Sutter R, Gotschi T, Tanadini M, Rosskopf AB. A Randomized Trial of Intra-articular Injection Therapy for Knee Osteoarthritis. Invest Radiol. 2023 May 1;58(5):355-362. doi: 10.1097/RLI.0000000000000942. Epub 2022 Dec 27.
PubMed 36728848
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraarticular Injections of Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02776514
- Acronym / sponsor ID
- KIT / W-560
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- Stiftung für Rheumaforschung Zurich, Stiftung Marie-Lou Ringgenberg Bern
- Study start
- Feb 2016
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 18 May 2016 (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 study investigates clinical outcome and imaging outcome parameters after intraarticular injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients with early osteoarthritis of the knee joint.
Detailed description
Osteoarthritis of the knee joint is a very common disease in middle aged and elderly patients. This study evaluates the efficiency of different commonly used substances for intraarticular, non-operative treatment in early stages of this disease.
120 patients receive an fluoroscopic guided injection in the knee joint: 30 patients get injection with steroids 30 patients get injection with prp 30 patients get injection with hyaluronic acid 30 patients get injection with placebo (iopamiro contrast media)
Primary outcome: - clinical outcome (pain using numeric rating scale)
- Magnetic Resonance imaging (cartilage defects etc.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Triamcort (1 ml, 40 mg/ml) | Active comparator | Drug: Triamcort30 patients receive intraarticular injection with steroids (and contrast media Iopamiro 200) |
| Platelet-rich-plasma (PRP 3 ml) | Active comparator | Drug: Platelet-rich-plasma30 patients receive intraarticular injection with platelet-rich-plasma (PRP) (and contrast media Iopamiro 200) |
| Suplasyn1-shot (60 mg/ ml) | Active comparator | Drug: Suplasyn130 patients receive intraarticular injection with hyaluronic acid (and contrast media Iopamiro 200) |
| Placebo (Iopamiro 200) | Placebo comparator | Drug: Placebo30 patients receive intraarticular injection with contrast media only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- gonarthritis Kellgren 1,2,3 with symptoms
- german speaking
- informed consent
Key exclusion criteria (1 listed)
- -age under 18, gonarthritis, Kellgren 4, anticoagulation therapy, known inflammatory disease or infection, cardiovascular disease NYHA IV, immunosuppression, contraindication for MRI, pregnancy, no informed consent, NSAR 3 days before injection, etc.
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 |
|---|---|---|
| TriamcortFluoroscopic guided injection in the knee joint | Drug | Triamcort (1 ml, 40 mg/ml) |
| Platelet-rich-plasma | Drug | Platelet-rich-plasma (PRP 3 ml) |
| Suplasyn1 | Drug | Suplasyn1-shot (60 mg/ ml) |
| Placebo | Drug | Placebo (Iopamiro 200) |
Primary outcome
Pain assessment
Time frame: up to 24 months after injection
numeric rating scale (NRS) and WOMAC
Magnetic Resonance imaging
Time frame: up to 12 months after injection
cartilage volume (ml)
Magnetic Resonance imaging
Time frame: up to 12 months after injection
T2-values in cartilage (mean Signal +/- Standard Deviation) in subregions
3 secondary outcomes
WOMAC score (stiffness, difficulty)
Time frame: up to 24 months after injection
Tegner Activity Scale
Time frame: up to 24 months after injection
Knee mobility and thigh circumference
Time frame: 3 month after injection
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 7 Feb 2022.
- Derived from this study: PubMed 38421679Tschopp M, Pfirrmann CWA, Brunner F, Fucentese SF, Galley J, Stern C, Sutter R, Catanzaro S, Kuhne N, Rosskopf AB. Morphological and Quantitative Parametric MRI Follow-up of Cartilage Changes Before and After Intra-articular Injection Therapy in Patients With Mild to Moderate Knee Osteoarthritis: A Randomized, Placebo-Controlled Trial. Invest Radiol. 2024 Sep 1;59(9):646-655. doi: 10.1097/RLI.0000000000001067. Epub 2024 Feb 28.
- Derived from this study: PubMed 36728848Tschopp M, Pfirrmann CWA, Fucentese SF, Brunner F, Catanzaro S, Kuhne N, Zwyssig I, Sutter R, Gotschi T, Tanadini M, Rosskopf AB. A Randomized Trial of Intra-articular Injection Therapy for Knee Osteoarthritis. Invest Radiol. 2023 May 1;58(5):355-362. doi: 10.1097/RLI.0000000000000942. Epub 2022 Dec 27.
- Individual participant dataSharing planned: No
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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.
Andrea B Rosskopf, MD principal investigator
Radiology University Hospital Balgrist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triamcort, Platelet-rich-plasma and Suplasyn1 in people with Osteoarthritis, Knee, run by Balgrist University Hospital at 1 site in Switzerland.
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 1 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 7 Feb 2022. 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain assessment (time frame: up to 24 months after injection). The study lists 3 primary outcomes in all. 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 NCT02776514, which also lists 2 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 7 Feb 2022.