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临床试验/NCT07736716
NCT07736716已完成不适用

Arthroscopic Mechanical Release of the Infrapatellar Fat Pad Mobilizes Cells With a Mesenchymal Stem Cell Immunophenotype and Alters Early Molecular Responses.

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Number of Cells With a Mesenchymal Stem Cell Immunophenotype Before and After Infrapatellar Fat Pad Release

研究概览

简要总结

This prospective, single-center, paired-sample clinical laboratory study evaluated whether controlled mechanical release of the infrapatellar fat pad during knee arthroscopy increases the number of intra-articular cells with a mesenchymal stem cell immunophenotype. The study also evaluated whether the procedure is accompanied by immediate changes in the expression of selected genes associated with inflammation, immunomodulation, and tissue repair.

Adults undergoing knee arthroscopy for meniscal pathology had a 20-mL intra-articular fluid sample collected before manipulation of any intra-articular structure. The infrapatellar fat pad was then gently and selectively shaved for approximately 1 minute using a motorized arthroscopic shaver with the suction turned off. A second 20-mL intra-articular fluid sample was collected immediately after the procedure and before further irrigation or continuation of the planned arthroscopic surgery.

Paired pre-release and post-release samples were analyzed by flowcytometry to quantify cells with a mesenchymal stem cell immunophenotype. Quantitative real-time polymerase chain reaction was performed on the total cellular fraction to assess IL-1β, IL-6, IL-10, TGF-β, and CD24 gene expression. Comparisons were performed within each participant using the paired samples.

详细描述

Cell-based orthobiologic strategies commonly require tissue harvesting from an extra-articular donor site, ex vivo processing, and subsequent intra-articular administration. The infrapatellar fatpad is a local intra-articular adipose tissue source containing cells with mesenchymal stem cell-related properties. However, it remains unclear whether cells with a mesenchymal stem cell immunophenotype can be directly mobilized into the joint fluid during routine knee arthroscopy and whether this mobilization is accompanied by an immediate molecular response.

This was a prospective, single-center, paired-sample clinical laboratory study involving adults undergoing routine knee arthroscopy for meniscal pathology. Participants were prospectively enrolled between January 2024 and January 2025. The study was designed as a within-participant comparison of paired intra-articular fluid samples collected immediately before and after controlled mechanical release of the infrapatellar fat pad.

Knee arthroscopy was performed through standard anterolateral and anteromedial portals. Sterile 0.9% saline was initially introduced to distend the joint and obtain adequate visualization. After visualization of the joint, fluid inflow was stopped, and no intra-articular structure was manipulated before baseline sampling. A 20-mL intra-articular fluid sample was aspirated using a sterile syringe and divided into two equal 10-mL aliquots as the pre-release sample.

Following baseline sampling, a motorized arthroscopic shaver was introduced through the anteromedial portal. With the shaver suction turned off, the infrapatellar fat pad was gently and selectively shaved for approximately 1 minute. Care was taken to avoid contact with the menisci, articular cartilage, cruciate ligaments, and synovial structures outside the intended release area.

Immediately after controlled mechanical release of the infrapatellar fat pad, and before further irrigation or continuation of the planned arthroscopic procedure, a second 20-mL intra-articular fluid sample was collected under the same conditions. This sample was divided into two equal 10-mL aliquots as the post-release sample. No additional fluid was introduced into the joint between the pre-release and post-release sampling procedures. After collection of the post-release sample, the released tissue was removed using routine arthroscopic suction and irrigation, and the planned arthroscopic procedure was completed.The timing, sample volume, portal use, release technique, and specimen handling were standardized across participants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 55 years
  • Presence of knee pain
  • Meniscal tear confirmed by magnetic resonance imaging
  • Scheduled to undergo arthroscopic knee surgery
  • Provision of written informed consent to participate in the study

排除标准

  • Requirement for emergency surgery
  • Open injury involving the knee
  • Severe anterior or posterior cruciate ligament injury causing substantial knee instability
  • Tibial eminence fracture
  • Osteochondral defect requiring surgical treatment
  • Planned open knee surgery
  • Suspected septic arthritis
  • Inflammatory arthritis
  • Suspected intra-articular tumor
  • Previous arthroscopic surgery on the same knee
  • Declining to participate in the study

结局指标

主要结局

Number of Cells With a Mesenchymal Stem Cell Immunophenotype Before and After Infrapatellar Fat Pad Release

时间窗: Immediately before and immediately after the approximately 1-minute infrapatellar fat pad release procedure during the same knee arthroscopy

The number of LIN-negative, CD29-positive, CD73-positive, CD13-positive, CD105-positive, CD90-positive, and CD31-negative cells was quantified by flow cytometry in standardized paired intra-articular fluid samples collected before and immediately after controlled mechanical release of the infrapatellar fat pad. Paired cell counts were summarized as median with minimum and maximum values and compared within participants.

次要结局

  • Fold Change in IL-1β Gene Expression After Infrapatellar Fat Pad Release(Immediately before and immediately after the approximately 1-minute infrapatellar fat pad release procedure during the same knee arthroscopy)
  • Fold Change in IL-6 Gene Expression After Infrapatellar Fat Pad Release(Immediately before and immediately after the approximately 1-minute infrapatellar fat pad release procedure during the same knee arthroscopy)
  • Fold Change in IL-10 Gene Expression After Infrapatellar Fat Pad Release(Immediately before and immediately after the approximately 1-minute infrapatellar fat pad release procedure during the same knee arthroscopy)
  • Fold Change in TGF-β Gene Expression After Infrapatellar Fat Pad Release(Immediately before and immediately after the approximately 1-minute infrapatellar fat pad release procedure during the same knee arthroscopy)
  • Fold Change in CD24 Gene Expression After Infrapatellar Fat Pad Release(Immediately before and immediately after the approximately 1-minute infrapatellar fat pad release procedure during the same knee arthroscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İbrahim Alper YAVUZ

Associate Professor of Orthopaedics and Traumatology

Ankara City Hospital Bilkent

研究点 (1)

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