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Knee OAPhase 2NCT04315103

a Single HYAJOINT Plus Combined With a Single PPR Versus a Single PRP for Knee OA

A Phase 2 study testing a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP in people with Knee OA, run by Kaohsiung Veterans General Hospital. at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intraarticular hyaluronan or platelet-rich plasma (PRP) is each effective in the treatment for knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP for knee OA remained unclear. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Knee OA
What is being tested?
a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
2 sitesTaiwan
Study dates
1 Aug 2018to 10 Jul 2019
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 20-75 years;Symptomatic knee OA > 6 months despite conservative treatment such as oral analgesics, NSAIDs and/or physical therapy;Kellgren-Lawrence grades 2 knee OA on radiographs taken within the previous 6 months;Average pain at walking > 30 mm on a 100-mm visual analog scale (VAS);Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee< 30 mm.

Who cannot join

  • Previous orthopedic surgery on the spine or lower limbs Disabling OA of either hip or foot Knee instability, apparent joint effusion or marked valgus/varus deformity Known allergy to hyaluronan products Women ascertained or suspected pregnancy or lactating Intraarticular injections into the knee in the past 6 months Any specific medical conditions (rheumatoid arthritis, active infections, severe cardiovascular diseases, autoimmune diseases, hemiparesis, neoplasm, etc.) that would interfere with the assessments

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Department of Physical Medicine and Rehabilitation, Veterans General Hospital,

    Kaohsiung City, 813

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

Other trials in Taiwan

About this study

Official title: Efficacy of a Single Crosslinked Hyaluronan (HYAJOINT Plus) Combined With a Single Platelet-rich Plasma (PRP) Versus a Single PRP for the Treatment of Knee Osteoarthritis: A Randomized-Controlled Trial

Intraarticular hyaluronan or platelet-rich plasma (PRP) is each effective in the treatment for knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP for knee OA remained unclear. This study aimed to investigate the efficacy of a single intraarticular hyaluronan (HYAJOINT Plus) combined with a single PRP versus a single intraarticular PRP in patients with knee OA.

Read the detailed description

Intraarticular HA or PRP has been used for knee OA for years. Combined HA and PRP has not been widely used for OA because of lack of clinical evidence. Based on in vitro and animal studies, combining HA and PRP may benefit from their dissimilar biological mechanisms for tissue repair and have potentials to synergistically promote cartilage regeneration, inhibit OA inflammation, modulate the disease process, and improve joint homeostasis in OA. Combination of HA and PRP has much potential for the treatment of OA, but the clinical evidence of this combination remains unclear. The purpose of this study was to investigate the efficacy and safety of combined a single crosslinked HA (HYAJOINT Plus) with a single PRP versus a single PRP alone in patients with knee OA.

Conditions
Knee OA
Being tested
a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP
Keywords
Hyaluronan, Knee osteoarthritis, Platelet-rich plasma
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRPCombination product

    Also called the one-injection group received a single injection of 3 ml PRP

    All the injections were done by the same experienced physician using aseptic procedures.

Study groups in NCT04315103
Study groupRoleWhat they receive
the combined-injection groupExperimentalpatients received a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP
Receives: Combination Product: a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP
the one-injection groupActive comparatorpatients received a single injection of 3 ml PRP
Receives: Combination Product: a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS pain score change from baseline

    . The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0=no pain to 100=worst possible pain)

    Measured: 1,3 and 6 months

Secondary outcomes (5)

  1. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale)

    a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and higher scores indicate worse outcomes.

    Measured: 1,3 and 6 months

  2. Lequesne index

    used to assess severity of knee symptoms during the last week. It includes the measurement of pain, walking distance, and activities of daily living. Maximal score is 24 and higher scores represent worse function.

    Measured: 1,3 and 6 months

  3. Single-leg stance test (SLS)

    done by raising one foot up without touching it to the supported lower extremity with target knee and maintain balance for as long as possible. Each participant performed 3 trials, and the best result of the 3 trials was recorded.

    Measured: 1,3 and 6 months

  4. satisfaction

    Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied).

    Measured: 1,3 and 6 months

  5. consumption of analgesics

    Acetaminophen (500mg; maximum daily dose, 4 g) was the only rescue medication allowed for knee pain. Acetaminophen was not permitted during the 24-hour period prior to each study visit. Use of rescue medication during the study period was recorded in a patient diary.

    Measured: 1,3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2020
  2. Study start1 Aug 2018
  3. Primary completion10 Jan 2019
  4. Study completion10 Jul 2019

Resources

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
Model description
Patients with symptomatic knee OA were randomized to receive a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP (the combined-injection group) or a single injection of 3 ml PRP (the one-injection group).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04315103
Sponsor's protocol ID
VGHKS107-152
Status last verified
Mar 2020
First submitted
18 Mar 2020
Last updated
19 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sun SF, Lin GC, Hsu CW, Lin HS, Liou IS, Wu SY. Comparing efficacy of intraarticular single crosslinked Hyaluronan (HYAJOINT Plus) and platelet-rich plasma (PRP) versus PRP alone for treating knee osteoarthritis. Sci Rep. 2021 Jan 8;11(1):140. doi: 10.1038/s41598-020-80333-x.

    PubMed 33420185

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP in people with Knee OA, run by Kaohsiung Veterans General Hospital. at 2 sites in Taiwan.

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 1 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 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. 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.

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?

VAS pain score change from baseline (time frame: 1,3 and 6 months). 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 NCT04315103, which also lists 1 linked publication.

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 19 Mar 2020.

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