NCT07736716

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

infrapatellar fatpadmesenchymal stem cellsknee arthroscopymechanical releaseflowcytometrygene expression

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (5)

  • 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

Study Arms (1)

Arthroscopic Infrapatellar Fat Pad Release

EXPERIMENTAL

Participants undergoing routine knee arthroscopy for meniscal pathology underwent paired intra-articular fluid sampling. A 20-mL baseline sample was collected before any intra-articular manipulation. The infrapatellar fat pad was then gently and selectively shaved for approximately 1 minute using a motorized arthroscopic shaver with the suction temporarily turned off. A second 20-mL intra-articular fluid sample was collected immediately after shaving and before further irrigation. The released tissue was subsequently removed using routine arthroscopic suction and irrigation, and the planned arthroscopic procedure was completed.

Procedure: Controlled Mechanical Release of the Infrapatellar Fat Pad

Interventions

After baseline intra-articular fluid sampling, the infrapatellar fat pad was gently and selectively shaved for approximately 1 minute with the motorized arthroscopic shaver suction temporarily turned off. A second intra-articular fluid sample was collected immediately after shaving and before further irrigation. The released tissue was subsequently removed using routine arthroscopic suction and irrigation. No released tissue or cells were intentionally retained in the joint for therapeutic purposes.

Arthroscopic Infrapatellar Fat Pad Release

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ibrahim a yavuz, MD, PhD

    Ankara Bilkent City Hospital, Department of Orthopedics and Traumatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopaedics and Traumatology

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start

January 9, 2024

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because specific participant consent for external data sharing was not obtained.

Locations