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Not yet recruitingNCT05795660Updated Apr 3, 2023

The Effect of Platelet Rich Plasma for the Treatment of Osteochondral Lesions of the Talus

A Phase 1 interventional study of platelet rich plasma in Osteochondral Lesions of the Talus, sponsored by Ministry of Health, Kuwait. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-04-03.

Sponsored by Ministry of Health, Kuwait · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Osteochondral lesion of the talus (OCL) results from the detachment of the talar cartilage which could also be associated with subchondral bone fragmentation due to trauma. OCL can be managed conservatively by immobilization and weight bearing restriction or surgically to stimulate the regeneration and the formation of fibrous cartilage including reparative or replacement approaches. OCL surgical intervention includes bone marrow stimulation or autologous osteochondral transplantation while the cartilage regeneration was found unsatisfactory with these interventions. However, introducing platelet rich plasma (PRP) as an adjacent intervention could enhance the cartilage regeneration in OCL due to the release of growth factors and bioactive components, which could in turn reduce the need for replacement interventions and improve the regeneration of the cartilage.

The literature was reviewed, and four randomized controlled trials have been found exploring the effect of PRP in OCL where both ankle function and pain were examined. The results of the previous studies have proved the effectiveness of PRP in managing OCL as an adjunct to microfracture surgery in improving ankle function and reducing pain which was superior to the surgical intervention alone and also superior to the injection of PRP alone. Despite the promising results, the previous studies were limited to several factors. There was a lack of blinding which could risk the results to expectation bias, and the follow up period was short in according to the MCMS, which is needed to monitor the long-term effect of the PRP and to document any potential adverse effects or relapse in the function. Additionally, all the previous studies performed blind injection. Additionally, the previous studies have not controlled the administration of analgesic which could risk the results of the pain effect.

The proposed study aims to examine the effect of PRP in the management of OCL using randomized double-blind control trial design to eliminate any expectation bias. Patients will be followed up for 12 months, and the PRP will be administered intra-operatively. Moreover, PRP concentration will be standardized. Analgesic will be controlled and documented as a confounded factor. Additionally, the quality of the repaired tissue and the regeneration of the hyaline cartilage will be examined using MRI at the end of the follow-up. Therefore, the study aims to examine the effectiveness of PRP in OCL using randomized controlled trial design.

02

Conditions studied

  • Osteochondral Lesions of the Talus
03

In context

Lead sponsor

Ministry of Health, Kuwait is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of OCL, which will be confirmed with radiographs and magnetic resonance imaging.
  • aged > or = 18 years \< 60 year
  • complain of ankle pain.

Exclusion criteria

Exclusion Criteria:

  • posterior OCL
  • pregnancy
  • ankle infection
  • teroid injection within 6 months
  • surgery of the involved joint with 6 months
  • received glucosamine and/or chondroitin sulfate, or anticoagulant
  • Systematic inflammatory condition
  • substantial venous or lymphatic stasis in the legs
  • Pathologies that my confound pain and functional assessment in the ankle (plantar fasciitis, Achilles tendonitis, sprains, and degenerative joint disease of the foot.
  • Allergy to any of the component of the PRP injection, disabling degenerative joint disease.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Osteochondral lesions of the talus group

    Patients will receive PRP injection.

    Biological: platelet rich plasma

  • Placebo comparator
    Control group

    Patients will receive saline injection.

    Biological: platelet rich plasma

Interventions

  • Biologicalplatelet rich plasma

    platelet rich plasma injection

    Also known as: platelet rich plasma injection

06

What researchers measure

Primary outcomes

  1. American Orthopedic Foot and Ankle (AOFAS) score

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Data will be available upon request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05795660
Lead sponsor
Ministry of Health, Kuwait
Responsible party
Meshal Alhadhoud (Head of Orthopedic Surgery Department, Ministry of Health, Kuwait) — Principal investigator
First posted
Apr 3, 2023
Start date
Apr 1, 2023 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Apr 3, 2023

Study contacts

Najla Alsiri, PhD
Contact
dr.alsiri@outlook.com
00965-66820032

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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