Ankle InstabilityNCT03197428
Platelet-rich Plasma for Chronic Lateral Ankle Instability
A study testing Platelet-rich plasma in people with Ankle Instability and Platelet-rich Plasma, run by Pei-Yuan Lee, MD at 1 site in Taiwan.
Trial summary
This study aims to evaluate the effect of platelet-rich plasma (PRP) on chronic lateral ankle instability by comparing the imaging and clinical outcomes between patients receiving PRP and those receiving whole blood during the modified Broström-Gould procedure. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ankle Instability, Platelet-rich Plasma
- What is being tested?
- Platelet-rich plasma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jul 2016to 31 Jan 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 60 years
- With diagnosis of chronic lateral ankle instability
Who cannot join
- Poor controlled diabetes
- Peripheral artery obstructive disease
- Skin or soft tissue infection at ankle
- With current or prior history of ankle disease, including degeneration arthritis, fracture, deformity, and cartilage disease.
- With prior history of ankle surgery
- With current or prior history of cancer
- With current or prior history of hematological disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability
This study aims to evaluate the effect of platelet-rich plasma (PRP) on chronic lateral ankle instability by comparing the imaging and clinical outcomes between patients receiving PRP and those receiving whole blood during the modified Broström-Gould procedure.
Read the detailed description
Chronic lateral ankle instability (CAI) in a common foot and ankle problem. It has been linked to recurrent ankle pain, swelling, and even early degenerative change if not properly treated. Lateral ligament reconstruction using modified Broström-Gould procedure is the mainstream in treatment of CAI. Early mobilization is related to better functional outcome, and rapid healing of the repair is the key point to shorten the immobilization time. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration. However, there is no conclusion regarding the efficacy of PRP on CAI. This clinical trial will investigate the effect of PRP on CAI. Eligible patients will be randomly assigned to receive PRP or whole blood during the modified Broström-Gould procedure. The postoperative imaging and clinical outcomes will be compared and analyzed.
- Conditions
- Ankle Instability, Platelet-rich Plasma
- Being tested
- Platelet-rich plasma, Control
- Keywords
- Platelet-Rich Plasma, Ankle Injuries, Lateral Ligament, Ankle
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasmaOther
Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament
ControlOther
Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | 15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament. Receives: Other: Platelet-rich plasma |
| Control group | Placebo comparator | 15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score
Ankle function is evaluated by AOFAS Ankle-Hindfoot score
Measured: 3-month postoperative
Secondary outcomes (5)
3-month postoperative ankle pain evaluated by visual analogue scale
Ankle pain is evaluated by visual analogue scale
Measured: 3-month postoperative
3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test
Anterior displacement is evaluated by the anterior displacement of the talus relative to the tibia on stress radiographs of anterior drawer test.
Measured: 3-month postoperative
3-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test
Lateral tilt of ankle is evaluated by stress radiographs of talar tilt test.
Measured: 3-month postoperative
Percentage of patients with healed ligament evaluated by MRI
Healing condition of ligament is assessed by MRI.
Measured: 3-month postoperative
Percentage of patients with healed ligament evaluated by second look arthroscopy
Healing condition of ligament is assessed by second look arthroscopy.
Measured: 3-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start5 Jul 2016
- Primary completion12 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InstabilityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pei-Yuan Lee, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Responsible party
- Sponsor-investigator, Pei-Yuan Lee, MD, Show Chwan Memorial Hospital
- Investigators
- Pei-Yuan Lee, MD, Study chair, Show Chwan Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197428
- Sponsor's protocol ID
- RA-16026-RD-105066
- Status last verified
- Apr 2019
- First submitted
- 13 Apr 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-rich Plasma in the Treatment of Chronic Lateral Ankle Instability
- ClinicalTrials.gov ID
- NCT03197428
- Acronym / sponsor ID
- RA-16026-RD-105066
- Conditions
- Ankle Instability, Platelet-rich Plasma
- Keywords
- Platelet-Rich Plasma, Ankle Injuries, Lateral Ligament, Ankle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pei-Yuan Lee, MDUniversity, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 12 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 23 Jun 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.
This study aims to evaluate the effect of platelet-rich plasma (PRP) on chronic lateral ankle instability by comparing the imaging and clinical outcomes between patients receiving PRP and those receiving whole blood during the modified Broström-Gould procedure.
Detailed description
Chronic lateral ankle instability (CAI) in a common foot and ankle problem. It has been linked to recurrent ankle pain, swelling, and even early degenerative change if not properly treated. Lateral ligament reconstruction using modified Broström-Gould procedure is the mainstream in treatment of CAI. Early mobilization is related to better functional outcome, and rapid healing of the repair is the key point to shorten the immobilization time. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration. However, there is no conclusion regarding the efficacy of PRP on CAI. This clinical trial will investigate the effect of PRP on CAI. Eligible patients will be randomly assigned to receive PRP or whole blood during the modified Broström-Gould procedure. The postoperative imaging and clinical outcomes will be compared and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Other: Platelet-rich plasma15 patients will receive platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament. |
| Control group | Placebo comparator | Other: Control15 patients will receive whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 20 and 60 years
- With diagnosis of chronic lateral ankle instability
Key exclusion criteria (8 listed)
- Poor controlled diabetes
- Peripheral artery obstructive disease
- Skin or soft tissue infection at ankle
- With current or prior history of ankle disease, including degeneration arthritis, fracture, deformity, and cartilage disease.
- With prior history of ankle surgery
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 |
|---|---|---|
| Platelet-rich plasmaPlatelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament | Other | PRP group |
| ControlWhole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament | Other | Control group |
Primary outcome
3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score
Time frame: 3-month postoperative
Ankle function is evaluated by AOFAS Ankle-Hindfoot score
5 secondary outcomes
3-month postoperative ankle pain evaluated by visual analogue scale
Time frame: 3-month postoperative
3-month postoperative anterior displacement of ankle evaluated by stress radiographs of anterior drawer test
Time frame: 3-month postoperative
3-month postoperative lateral tilt of ankle evaluated by stress radiographs of talar tilt test
Time frame: 3-month postoperative
Percentage of patients with healed ligament evaluated by MRI
Time frame: 3-month postoperative
Percentage of patients with healed ligament evaluated by second look arthroscopy
Time frame: 3-month postoperative
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 4 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Ankle Instability
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
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.
Pei-Yuan Lee, MD study chair
Show Chwan Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich plasma in people with Ankle Instability and Platelet-rich Plasma, run by Pei-Yuan Lee, MD 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 2 inclusion and 8 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 4 Apr 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. 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.
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?
3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score (time frame: 3-month postoperative). 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 4 Apr 2019.