Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03197428
Other study ID # RA-16026-RD-105066
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2016
Est. completion date January 31, 2019

Study information

Verified date April 2019
Source Show Chwan Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 31, 2019
Est. primary completion date January 12, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Age between 20 and 60 years

- With diagnosis of chronic lateral ankle instability

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Platelet-rich plasma
Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament
Control
Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament

Locations

Country Name City State
Taiwan Show Chwan Memorial Hospital Changhua City Changhua

Sponsors (2)

Lead Sponsor Collaborator
Pei-Yuan Lee, MD Aeon Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 3-month postoperative ankle function evaluated by AOFAS Ankle-Hindfoot score Ankle function is evaluated by AOFAS Ankle-Hindfoot score 3-month postoperative
Secondary 3-month postoperative ankle pain evaluated by visual analogue scale Ankle pain is evaluated by visual analogue scale 3-month postoperative
Secondary 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. 3-month postoperative
Secondary 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. 3-month postoperative
Secondary Percentage of patients with healed ligament evaluated by MRI Healing condition of ligament is assessed by MRI. 3-month postoperative
Secondary Percentage of patients with healed ligament evaluated by second look arthroscopy Healing condition of ligament is assessed by second look arthroscopy. 3-month postoperative
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05483634 - Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
Not yet recruiting NCT05096650 - Platelet Rich Plasma for Treatment of Facial Photoaging: A Double-blind, Randomized, Split-face Study N/A
Completed NCT03667638 - Influence of Platelet Concentrates on Wound Healing N/A
Recruiting NCT04972331 - Degenerative Meniscus Without Osteoarthritis : Arthroscopic Partial Menisectomy Versus Platelet Rich Plasma (APM-PRP) N/A
Recruiting NCT06440655 - The Efficacy and Safety of Platelet-rich Fibrin and Platelet Rich Plasma in Female Pattern Hair Loss Patients N/A
Completed NCT04351087 - Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial N/A
Completed NCT03220334 - Healing Effects of Autologous Platelet Rich Plasma on Gastric Ulcer Caused by Endoscopic Submucosal Dissection Phase 3
Recruiting NCT04040283 - Platelet-rich Plasma for Menical Tear
Not yet recruiting NCT03859843 - Efficacy and Antimicrobial Activity of Platelet Rich Plasma (PRP) in Acne Vulgaris Phase 3
Completed NCT05585216 - The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq N/A
Completed NCT05925829 - Stromal Vascular Fraction and Autologous Activated Platelet-Rich Plasma Combination in Treating Treatment of Type 2 Diabetes Phase 1
Completed NCT04350827 - PRP vs PRP Plus IGF for Patellar Tendinosis N/A
Completed NCT04522674 - Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine Early Phase 1
Not yet recruiting NCT03779945 - Effect of Platelet-Rich-Plasma in Spine Fusion Phase 4
Completed NCT03197441 - Platelet Rich Plasma for Knee Osteoarthritis N/A
Completed NCT03176641 - Platelet-rich Plasma for Meniscus Repair N/A
Completed NCT02931149 - Evaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection Techniques Phase 3
Recruiting NCT05230667 - Comparison of the Effect of Combined Glenohumeral Joint and Subdeltoid Bursa Injection With Platelet-rich Plasma (PRP), Corticosteroid, and Normal Saline in Addition to Physical Therapy for Treatment of Frozen Shoulder N/A
Completed NCT03197415 - Platelet-rich Plasma for Low Back Pain N/A