Clinical trial NCT03792594: Autologous Bone Marrow Concentration for Rotator Cuff Tear
Official title: The Effect of Autologous Bone Marrow Concentration Combined With Arthroscopy for Rotator Cuff Tear
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Tear
Bone Marrow
Keywords: Bone Marrow
Mesenchymal Stromal Cells
Rotator Cuff Tear
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Aeon Biotechnology Corporation
First posted: 2019-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive eligible patients who underwent arthroscopic repair combined with autologous bone marrow stem cells treatment for rotator cuff tear

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-month postoperative shoulder function evaluated by Constant Shoulder Score
timeFrame: 3-month postoperative
Secondary outcomes:
measure: 6-month postoperative shoulder function evaluated by Constant Shoulder Score
timeFrame: 6-month postoperative
measure: 12-month postoperative shoulder function evaluated by Constant Shoulder Score
timeFrame: 12-month postoperative
measure: 3-month postoperative degree of healing evaluated by plain radiograph
timeFrame: 3-month postoperative
measure: 6-month postoperative degree of healing evaluated by plain radiograph
timeFrame: 6-month postoperative
measure: 12-month postoperative degree of healing evaluated by plain radiograph
timeFrame: 12-month postoperative
measure: 6-month postoperative degree of healing evaluated by MRI
timeFrame: 6-month postoperative
measure: 12-month postoperative degree of healing evaluated by MRI
timeFrame: 12-month postoperative
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
state: Changhua
Study officials:
affiliation: Show Chwan Memorial Hospital
name: Pei-Yuan Lee, MD
role: STUDY_CHAIR
References: