Autologous Bone Marrow Concentration for Rotator Cuff Tear

P

Pei-Yuan Lee, MD

Status

Unknown

Conditions

Rotator Cuff Tear
Bone Marrow

Treatments

Other: arthroscopic repair with bone marrow concentration
Other: arthroscopic repair

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03792594
RD106055

Details and patient eligibility

About

This study aims to evaluate the effect of bone marrow concentration on healing of rotator cuff tear by comparing clinical and imaging outcomes between patients receiving arthroscopic repair with intraoperative bone marrow concentration and those receiving arthroscopic repair only.

Full description

Rotator cuff tear is a common cause of pain and disability among adults. Most tears are largely caused by the normal wear and tear that goes along with aging. Although nonsurgical treatment relieves pain and improves function in the shoulder, surgical repair for a torn rotator cuff is indicated if symptoms persisted or deteriorated after 3 months nonsurgical treatments, Recently, arthroscopic repair has become the mainstream of surgical repair for rotator cuff tear. However, the healing of a repaired tendon is not always predictable. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, some studies have shown that autologous bone marrow concentration can improve the healing of tendon grafts in a bone tunnel. Therefore, the goal of this study was to evaluate the effect of bone marrow concentration on healing of rotator cuff.

Enrollment

40 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • With diagnosis of rotator cuff tear
  • Age between 40 and 70 years

Exclusion criteria

  • With prior history of shoulder surgery
  • With current or prior history of trauma or infection at shoulder
  • With current diagnosis of coagulopathy
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup

Trial design

40 participants in 2 patient groups

Bone marrow concentration group
Description:
The patients receive arthroscopic repair with bone marrow concentration.
Treatment:
Other: arthroscopic repair with bone marrow concentration
Historical control group
Description:
The patients receive arthroscopic repair only
Treatment:
Other: arthroscopic repair

Trial contacts and locations

0

Loading...

Central trial contact

Pei-Yuan Lee, MD; Chien-Sheng Lo, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems