Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
ID06893302

Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial

Led by Hospital for Special Surgery, New York · Updated on 2026-04-27

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding bone marrow aspirate (BMA) injections during knee arthroscopy surgery can improve outcomes for patients with meniscal injuries, cartilage defects, or early osteoarthritis of the knee. This randomized, single-blind trial will enroll 50 adults aged 18 to 64 who need knee arthroscopy. The study aims to fill gaps in current knowledge about BMA's effects on patient-reported outcomes and to compare key laboratory counts between BMA and previously reported bone marrow concentrate products. Participants will be randomly assigned to one of two groups: one will receive standard arthroscopic debridement surgery with a saline injection, and the other will receive the same surgery plus an injection of about 4mL of bone marrow aspirate taken from the hip bone during surgery. A small portion of the aspirate will be sent for laboratory testing. The study will not evaluate bone marrow concentrate but focus on BMA alone. Patients will be followed for 12 months after surgery, completing questionnaires about pain, daily activities, and knee function at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. Researchers will collect multiple self-reported scores and one objective walking and stair climbing test. The main outcome measured will be the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months. This comprehensive follow-up aims to assess how adding BMA affects recovery and knee function over time.

CONDITIONS

Brief Title

Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Require primary knee arthroscopy for meniscal injury or focal cartilage defect
  • Have Kellgren-Lawrence grade 0 arthritis
  • Have Outerbridge cartilage grade 2 or lower
  • Aged 18 to 64 years
Not Eligible

You will not qualify if you...

  • Previous surgery on the same knee
  • Kellgren-Lawrence grade 3 or higher arthritis
  • Use of other orthopedic biologics within 3 months before surgery
  • Presence of ligament deficiencies
  • Need for meniscal repair
  • Need for osteotomy or other realignment surgery
  • Use of disease-modifying antirheumatic drugs (DMARDs) within last 3 months
  • History of anemia, bleeding disorders, or inflammatory joint diseases
  • History of metabolic bone diseases
  • Current pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery plus immediate recovery

Participants undergo arthroscopic debridement surgery of the knee, with some receiving an additional bone marrow aspirate (BMA) injection during the procedure.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 12 months

Participants are followed up to assess recovery and outcomes using self-reported scores and objective tests over 12 months.

Visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months (in-person)

Trial Site Locations

Total: 1 location

1

Hospital for Special Surgery

New York, New York, United States, 10021

Actively Recruiting

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Research Team

A

Akshay K Raghuram

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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