Effectiveness of Autologous Platelet-rich Plasma on Knee Cartilage Injury

NCT03024801 | Completed DMC

• 1 other identifier: ChinaPLAGH_003
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

To analyze the effectiveness of intra-articular injection of autologous PRP on knee cartilage repair and evaluating functional recovery of the knee joint in knee cartilage injury patients.

Conditions

Cartilage Injury

Outcome Measures

Primary Outcomes (1)

• Lysholm score

  To assess functional recovery of the knee joint. Lysholm score ranges from 0-100 with higher scores indicating better knee joint function. A score \<70 indicates damage to the knee joint function.

  at 3 months after final injection

Secondary Outcomes (2)

• 2000 IKDC Subjective Knee Evaluation Form score

  at 3 months after final injection

• Numerical rating scale score

  changes of month 1, month 2 and month 3 after initial injection, and month 3 after final injection

Study Arms (2)

autologous platelet-rich plasma group

EXPERIMENTAL

The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.

Drug: autologous platelet-rich plasma

normal saline group

EXPERIMENTAL

The patients with knee cartilage injury were randomized to the normal saline group.

Drug: normal saline

Interventions

autologous platelet-rich plasma DRUG

The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.

autologous platelet-rich plasma group

normal saline DRUG

The patients with knee cartilage injury were randomized to the normal saline group.

normal saline group

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Knee cartilage injury
• Having normal and stable joint motion but no deformity
• Focal cartilage defects confirmed by magnetic resonance imaging (MRI), Outerbridge classification III/IV with a defect size \< 10 cm2 graded as Outerbridge II at maximum
• Focal articular cartilage injury in the knee
• years of age
• Provision of signed informed consent to participate in the trial

You may not qualify if:

• Poor general condition
• Blood diseases
• Use of local hormone treatment within 3 months before the trial
• Bleeding tendency
• Drug addiction, including anesthetic, alcohol and poison
• Inflammatory arthropathy, including specific and non-specific arthritis and severe osteoarthritis
• Contagious viral infection
• Metabolic diseases, such as gout and rheumatism
• Pregnant or lactating, or planning to become pregnant within 1 year after the initial registration
• Unable to cooperate with rehabilitation therapy because of psychological/mental disorders

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Quanyi Guo, Ph.D

  Chinese PLA Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: February 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2016
• Last Updated: January 19, 2017

Record last verified: 2017-01