NCT06082531

Brief Summary

To evaluate the safety and effectiveness of PRP injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 9, 2025

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

October 9, 2023

Last Update Submit

April 6, 2025

Conditions

Platelets-rich PlasmaOsteoarthritis Knees BothMeniscus DisorderCartilage Injury

Keywords

platelets-rich plasmaOsteoarthritisCartilage InjuryMeniscus Injury

Outcome Measures

Primary Outcomes (3)

  • X-ray

    The postoperative plain X-ray film was utilized for the assessment of knee joint deformity, stenosis of the joint space, and hyperplasia of osteophytes.

    pre-operation,3 weeks after treatment, 6 months after treatment

  • CT

    The application of three-dimensional CT scan for the assessment of articular cartilage defects.

    pre-operation,3 weeks after treatment, 6 months after treatment

  • MRI

    The injury of ligaments, meniscus, and the knee joint was assessed using MRI.

    pre-operation,3 weeks after treatment, 6 months after treatment

Study Arms (3)

Preoperative

NO INTERVENTION

postoperative (6 weeks)

EXPERIMENTAL

The patients were injected with PRP.

Drug: Sodium hyaluronate injection

postoperative (3 months)

EXPERIMENTAL

The patients were injected with PRP.

Drug: Sodium hyaluronate injection

Interventions

Sodium hyaluronate injectionDRUG

The control group was injected into the joint cavity with sodium hyaluronate injection..

postoperative (3 months)postoperative (6 weeks)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The age range of the participants was 20 to 60 years old. Through a comprehensive clinical and imaging examination, it was conclusively determined that the individuals had knee osteoarthritis or experienced injuries to the cart, and meniscus surrounding the knee joint.
  • The preoperative routine tests and examinations revealed no contraindications.
  • Revised sentence: "Informed consent of the patient

You may not qualify if:

  • The platelet count or function exhibits significant abnormalities、Systemic infection transmitted through the bloodstream.
  • Prolonged usage of anti-inflammatory drugs and systemic corticoid administration.
  • In injection site or damage to the skin.
  • Patients with tumors or undergoing radiotherapy and chemotherapy.
  • Pregnant or breastfeeding women.
  • Individuals with mental illnesses who are unable to cooperate with follow-up procedures.
  • Contraindications for MRI、Patients or their families do consent to participate in the study.
  • Other circumstances that render participation in the study unsuitable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shannxi, 710034, China

RECRUITING

Related Publications (2)

  • Ramos-Gonzalez G, Salazar L, Wittig O, Diaz-Solano D, Cardier JE. The effects of mesenchymal stromal cells and platelet-rich plasma treatments on cutaneous wound healing. Arch Dermatol Res. 2023 May;315(4):815-823. doi: 10.1007/s00403-022-02451-y. Epub 2022 Nov 3.

    PMID: 36326886BACKGROUND

  • Zhang Y, Xing F, Luo R, Duan X. Platelet-Rich Plasma for Bone Fracture Treatment: A Systematic Review of Current Evidence in Preclinical and Clinical Studies. Front Med (Lausanne). 2021 Aug 3;8:676033. doi: 10.3389/fmed.2021.676033. eCollection 2021.

    PMID: 34414200BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Central Study Contacts

Yanyan Jia

CONTACT

+862984771794xiyyllwyh@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 13, 2023

Study Start

September 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 9, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)