Rotator Cuff TearNCT03792594
Autologous Bone Marrow Concentration for Rotator Cuff Tear
An observational study of Rotator Cuff Tear and Bone Marrow, run by Pei-Yuan Lee, MD at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Rotator Cuff Tear, Bone Marrow
- What is being tested?
- arthroscopic repair with bone marrow concentration and arthroscopic repair
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 May 2017to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive eligible patients who underwent arthroscopic repair combined with autologous bone marrow stem cells treatment for rotator cuff tear
Who may be able to join
- With diagnosis of rotator cuff tear
- Age between 40 and 70 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pei-Yuan Lee, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Show Chwan Memorial Hospital
Changhua, Changhua, 500
Chien-Sheng Lo, MD, +886-975611289, johnlcs@gmail.com
About this study
Official title: The Effect of Autologous Bone Marrow Concentration Combined With Arthroscopy for Rotator Cuff Tear
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.
Read the 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.
- Conditions
- Rotator Cuff Tear, Bone Marrow
- Being tested
- arthroscopic repair with bone marrow concentration, arthroscopic repair
- Keywords
- Bone Marrow, Mesenchymal Stromal Cells, Rotator Cuff Tear
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic repair with bone marrow concentrationOther
arthroscopic repair with bone marrow concentration
arthroscopic repairOther
arthroscopic repair only
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow concentration group | The patients receive arthroscopic repair with bone marrow concentration. Receives: Other: arthroscopic repair with bone marrow concentration | |
| Historical control group | The patients receive arthroscopic repair only Receives: Other: arthroscopic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month postoperative shoulder function evaluated by Constant Shoulder Score
Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Measured: 3-month postoperative
Secondary outcomes (7)
6-month postoperative shoulder function evaluated by Constant Shoulder Score
Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Measured: 6-month postoperative
12-month postoperative shoulder function evaluated by Constant Shoulder Score
Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Measured: 12-month postoperative
3-month postoperative degree of healing evaluated by plain radiograph
Degree of healing evaluated by plain radiograph
Measured: 3-month postoperative
6-month postoperative degree of healing evaluated by plain radiograph
Degree of healing evaluated by plain radiograph
Measured: 6-month postoperative
12-month postoperative degree of healing evaluated by plain radiograph
Degree of healing evaluated by plain radiograph
Measured: 12-month postoperative
6-month postoperative degree of healing evaluated by MRI
Degree of healing evaluated by MRI
Measured: 6-month postoperative
12-month postoperative degree of healing evaluated by MRI
Degree of healing evaluated by MRI
Measured: 12-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start12 May 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pei-Yuan Lee, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Responsible party
- Sponsor-investigator, Pei-Yuan Lee, MD, Show Chwan Memorial Hospital
- Investigators
- Pei-Yuan Lee, MD, Study chair, Show Chwan Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792594
- Sponsor's protocol ID
- RD106055
- Status last verified
- Apr 2020
- First submitted
- 2 Jan 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Autologous Bone Marrow Concentration Combined With Arthroscopy for Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT03792594
- Acronym / sponsor ID
- RD106055
- Conditions
- Rotator Cuff Tear, Bone Marrow
- Keywords
- Bone Marrow, Mesenchymal Stromal Cells, Rotator Cuff Tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pei-Yuan Lee, MDUniversity, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Study start
- 12 May 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow concentration group | – | Other: arthroscopic repair with bone marrow concentrationThe patients receive arthroscopic repair with bone marrow concentration. |
| Historical control group | – | Other: arthroscopic repairThe patients receive arthroscopic repair only |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive eligible patients who underwent arthroscopic repair combined with autologous bone marrow stem cells treatment for rotator cuff tear
Key inclusion criteria (2 listed)
- With diagnosis of rotator cuff tear
- Age between 40 and 70 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic repair with bone marrow concentrationarthroscopic repair with bone marrow concentration | Other | Bone marrow concentration group |
| arthroscopic repairarthroscopic repair only | Other | Historical control group |
Primary outcome
3-month postoperative shoulder function evaluated by Constant Shoulder Score
Time frame: 3-month postoperative
Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
7 secondary outcomes
6-month postoperative shoulder function evaluated by Constant Shoulder Score
Time frame: 6-month postoperative
12-month postoperative shoulder function evaluated by Constant Shoulder Score
Time frame: 12-month postoperative
3-month postoperative degree of healing evaluated by plain radiograph
Time frame: 3-month postoperative
6-month postoperative degree of healing evaluated by plain radiograph
Time frame: 6-month postoperative
12-month postoperative degree of healing evaluated by plain radiograph
Time frame: 12-month postoperative
6-month postoperative degree of healing evaluated by MRI
Time frame: 6-month postoperative
12-month postoperative degree of healing evaluated by MRI
Time frame: 12-month postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Yuan Lee, MD contact
Pei-Yuan Lee, MD study chair
Show Chwan Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear and Bone Marrow, run by Pei-Yuan Lee, MD at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Sheng Lo, MD (+886-975611289, johnlcs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-month postoperative shoulder function evaluated by Constant Shoulder Score (time frame: 3-month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.