Recruiting

Bone Marrow Aspiration

Sponsor:

Andrews Research & Education Foundation

Code:

NCT05573347

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rotator Cuff Repair

Bone Marrow Harvest

Study Details

Brief summary:

The goal of this observational clinical trial is to determine whether the posterior superior iliac spine of the hip or the humerus of the arm will produce larger amounts of bone marrow when harvested during surgery. Also, the secondary goal of this study is to determine the effects of the patient's position on the quantity of cells harvested from the hip, namely lying on back (prone) vs. lying on side (lateral decubitus). The main questions it aims to answer are:

  • Will the hip or the arm have more bone marrow extracted?
  • Does a patient lying in lateral decubitus position produce more bone marrow than lying in the prone position?

Participants that are to undergo rotator-cuff repair are eligible for this study. During the participant's repair, bone marrow will be extracted from the arm and from the hip. Half of the eligible participants will have bone marrow extracted from the hip while lying on their side, while the other half will have bone marrow extracted from the hip while lying on their back. Researchers will compare the results from both extraction sites on each patient, as well as compare results of the two patient position groups.

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Study ID

NCT05573347

Start date

Aug 16, 2022

Status verified date

Oct, 2022

Completion date

Aug 16, 2023

Anticipated

Primary completion date

Aug 16, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-80 years of age
  • Diagnosis of a rotator cuff tear requiring arthroscopic rotator cuff repair

Exclusion Criteria:

  • Patients who require superior capsular reconstruction or revision rotator cuff repair
  • Diabetes
  • Immune Disorders
  • Past medical history of a metastatic or other cancer which required chemotherapy/ radiation therapy
  • Rheumatoid arthritis
  • Is unable to comprehend the study documents or give informed consent

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Bone marrow harvest from side-lying patient

This group will have bone marrow harvested from the PSIS extraction site while lying in the lateral decubitus position.

Bone marrow harvest from patient lying prone

This group will have bone marrow harvested from the PSIS extraction site while lying in the prone position.

Interventions

Rotator Cuff Repair

Surgical repair of one or more ligament(s) that form the rotator cuff shoulder complex (supraspinatus, infraspinatus, subscapularis, and teres minor)

Bone Marrow Harvest

Procedure in which bone marrow cells are extracted, or harvested, from a given location in the body

Primary outcome measure

  • Hemocytometer (Sysmex) [ Time Frame: Upon day of surgical procedure (once per participant) ]

Central Contacts and Locations

Locations

Andrews Research and Education Foundation

Recruiting

Gulf Breeze, Florida, United States, 32561

Contacts

More Information

Sponsor

Andrews Research & Education Foundation

Last update posted

Oct 10, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrews Research & Education Foundation on 2022-10-10.