Ankle OsteoarthritisNCT04022928
A Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle OA
A study testing PRP in people with Ankle Osteoarthritis, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Platelet-rich plasma (PRP) has been reported to be an effective treatment for knee osteoarthritis (OA). The application in ankle OA has rarely been investigated. The aim was to evaluate the efficacy and safety of a single intraarticular injection of PRP for the treatment of patients with ankle OA. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Ankle Osteoarthritis
- What is being tested?
- PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2018to 30 May 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of at least twenty years
- Ankle pain lasted for at least 6 months, despite conservative treatment or inability to tolerate the side effects of medications
- Ankle radiographs taken within 6 months (reviewed by the senior author) were equivalent to grade 1-4 osteoarthritis by the Kellgren Lawrence grading system
- Average ankle pain of > 3cm on a 10-cm visual analog scale (VAS)
- Radiological evidence of bilateral ankle osteoarthritis was accepted if VAS pain in the contralateral ankle was < 3 cm
- Normal activity level, not bedridden or confined to a wheelchair, able to walk 30 meters without the aid of a walker, crutches or cane
- No use of physical therapy or changes in shoes or orthotic devices during the study
Who cannot join
- Pregnancy or lactation in women
- Lower leg trauma in a location other than within the ankle
- Previous surgery involving the spine, hip or knee
- The presence of an active infection of the ankle
- Surgery involving the affected ankle within the previous 12 months
- Intraarticular steroid or hyaluronate injection in the ankle within the previous 6 months
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- Treatment with anticoagulants or immunosuppressives
- History of rheumatoid arthritis, gout, or other inflammatory arthropathy
- The presence of visual or vestibular impairments
- Poor health status (such as a neoplasm, diabetes mellitus, or paresis) that would interfere with the assessments
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Veterans General Hospital Kaohsiung
Kaohsiung City, 813
About this study
Official title: Efficacy and Safety of a Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle Osteoarthritis-a Prospective Study
Platelet-rich plasma (PRP) has been reported to be an effective treatment for knee osteoarthritis (OA). The application in ankle OA has rarely been investigated. The aim was to evaluate the efficacy and safety of a single intraarticular injection of PRP for the treatment of patients with ankle OA.
Read the detailed description
Methods: In a prospective study, patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles. The primary outcome was the change from baseline in the visual analog scale (VAS) pain score (0-10cm) at 6 months. Secondary outcomes included the Ankle Osteoarthritis Scale (AOS) score, American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, single leg stance test (SLS), use of rescue analgesics and patient satisfaction. Adverse events were recorded during the study.
Patients were followed at 1, 3 and 6 months postinjection .
- Conditions
- Ankle Osteoarthritis
- Being tested
- PRP
- Keywords
- Ankle joint, Osteoarthritis, Platelet rich plasma
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPOther
, For PRP preparation, specialized platelet concentrate separator containing acid citrate dextrose as anticoagulant and a specific separator gel that harvest PR, preventing contamination of red blood cells and leukocytes were used.
| Study group | Role | What they receive |
|---|---|---|
| PRP injection | Experimental | Patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles. Receives: Other: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS) of ankle pain
The patient rated the average severity of ankle pain on ankle movement over the previous week on a 10-cm VAS (0=no pain to 10=worst possible pain)
Measured: 6 months
Secondary outcomes (6)
The Ankle Osteoarthritis Scale (AOS) score
AOS score is a validated patient-rated outcome measure that contains a nine-item pain subscale and a nine-item disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable
Measured: 6 months
The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score
a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment
Measured: 6 months
The single-leg stance (SLS) test
SLS test involved raising the unaffected foot, without touching it to the affected lower extremity, and maintaining balance for as long as possible. Each participant performed three trials, and the best result was recorded
Measured: 6 months
use of analgesic medication
The patient recorded the use of analgesic medication during the study period on a diary card.
Measured: through study completion, an average of 6 months
global satisfaction
The patients rated his or her level of global satisfaction relative to the state before the treatment, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied)
Measured: 6 months
safety of PRP for ankle
The safety of the injection was monitored by recording the occurrence of systemic and local adverse events on a diary card
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Jul 2018
- Primary completion30 Nov 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies 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
- Model description
- patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Fen Sun, Kaohsiung Veterans General Hospital.
- Investigators
- Shu Fen Sun, MD, Study director, Kaohsiung Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022928
- Sponsor's protocol ID
- VGHKS18-CT7-21
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle Osteoarthritis-a Prospective Study
- ClinicalTrials.gov ID
- NCT04022928
- Acronym / sponsor ID
- VGHKS18-CT7-21
- Conditions
- Ankle Osteoarthritis
- Keywords
- Ankle joint, Osteoarthritis, Platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 17 Jul 2019 (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.
Platelet-rich plasma (PRP) has been reported to be an effective treatment for knee osteoarthritis (OA). The application in ankle OA has rarely been investigated. The aim was to evaluate the efficacy and safety of a single intraarticular injection of PRP for the treatment of patients with ankle OA.
Detailed description
Methods: In a prospective study, patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles. The primary outcome was the change from baseline in the visual analog scale (VAS) pain score (0-10cm) at 6 months. Secondary outcomes included the Ankle Osteoarthritis Scale (AOS) score, American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, single leg stance test (SLS), use of rescue analgesics and patient satisfaction. Adverse events were recorded during the study.
Patients were followed at 1, 3 and 6 months postinjection .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles.
| Arm | Type | Receives |
|---|---|---|
| PRP injection | Experimental | Other: PRPPatients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of at least twenty years
- Ankle pain lasted for at least 6 months, despite conservative treatment or inability to tolerate the side effects of medications
- Ankle radiographs taken within 6 months (reviewed by the senior author) were equivalent to grade 1-4 osteoarthritis by the Kellgren Lawrence grading system
- Average ankle pain of > 3cm on a 10-cm visual analog scale (VAS)
- Radiological evidence of bilateral ankle osteoarthritis was accepted if VAS pain in the contralateral ankle was < 3 cm
Key exclusion criteria (10 listed)
- Pregnancy or lactation in women
- Lower leg trauma in a location other than within the ankle
- Previous surgery involving the spine, hip or knee
- The presence of an active infection of the ankle
- Surgery involving the affected ankle within the previous 12 months
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 |
|---|---|---|
| PRP, For PRP preparation, specialized platelet concentrate separator containing acid citrate dextrose as anticoagulant and a specific separator gel that harvest PR, preventing contamination of red blood cells and leukocytes were used. | Other | PRP injection |
Primary outcome
visual analog scale (VAS) of ankle pain
Time frame: 6 months
The patient rated the average severity of ankle pain on ankle movement over the previous week on a 10-cm VAS (0=no pain to 10=worst possible pain)
6 secondary outcomes
The Ankle Osteoarthritis Scale (AOS) score
Time frame: 6 months
The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score
Time frame: 6 months
The single-leg stance (SLS) test
Time frame: 6 months
use of analgesic medication
Time frame: through study completion, an average of 6 months
global satisfaction
Time frame: 6 months
safety of PRP for ankle
Time frame: through study completion, an average of 6 months
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 19 Jul 2019.
- 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.
Shu Fen Sun, MD study director
Kaohsiung Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP in people with Ankle Osteoarthritis, run by Kaohsiung Veterans General Hospital. at 1 site 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 7 inclusion and 10 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 Jul 2019. 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 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.
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?
visual analog scale (VAS) of ankle pain (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 19 Jul 2019.