Rotator Cuff TearsNCT04325789
Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years
A study testing nanofiber scaffold in people with Rotator Cuff Tears and Full-thickness Rotator Cuff Tears, run by Atreon Orthopedics at 4 sites in United States.
Trial summary
Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Rotator Cuff Tears, Full-thickness Rotator Cuff Tears
- What is being tested?
- nanofiber scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jun 2020to 30 Dec 2025
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 and older
- Able to provide informed consent
- Primary diagnosis of rotator cuff tear
Who cannot join
- Revision rotator cuff surgery
- Partial thickness rotator cuff tears
- Massive (greater than 5cm) rotator cuff tears
- Patients with current tobacco history
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Christ Hospital & The Lindner Reseach Center at The Christ Hospital
Cincinnati, Ohio, 45219
Central Indiana Orthopedics
Fishers, Indiana, 46037
Steadman Hawkins Clinic of the Carolinas - Patewood
Greenville, South Carolina, 29615
Associated Orthopedists of Detroit
Saint Clair Shores, Michigan, 48080
About this study
Official title: A Prospective Randomized Multicenter Evaluation of Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years
Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.
Read the detailed description
- INTRODUCTION This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures. Despite numerous advancements in surgical techniques and over 250,000 procedures currently performed annually in the United States, failure of tendon healing following rotator cuff surgery occurs frequently with reports as high as 94%. Nonhealing can lead to persistent pain, poor outcomes, and a significant economic burden to society when revision surgery is required. Several factors have been associated with poor tendon healing with age greater than 60 years shown to be a significant risk factor due to diminishing vascularity at the bone tendon interface where the tear typically originates. While numerous techniques have been devised to improve fixation over the past several decades, very few have been developed to address or enhance the biology at the repair site. Rotium nanofiber is a recent FDA approved scaffold (FDA 510(K) #K183236) that has been shown to improve tendon healing to bone in animal studies. It works to mimic the extracellular matrix and helps concentrates and bind cells at the repair site providing a better organizational structure of the healing tissue. The purpose of the current study is to assess if use of the scaffold significantly improves rotator cuff healing and enhances strength in patients at higher risk of perioperative failure of the repair.
- BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE Rotator cuff tears are a frequent cause of shoulder pain and disability in the elderly population. Typically, when conservative measures fail, surgery is often advised. A successful clinical outcome is felt to be heavily predicated on healing of the tendon to the bone. Despite numerous surgical and technical advancements over the past two decades not all repairs heal, with re-tear, or failure-to-heal, remaining the number one complication associated with rotator cuff surgery. This in turn creates a hefty economic burden on society whereupon surgeries are being performed with poor eventual outcomes and ultimately wasted resources. While reasons for failure are multifactorial, a strong correlation has been associated with advancing age. In an observational study on the natural history of rotator cuff disease, patients younger than 50 years old rarely had rotator cuff tears whereas those greater than 60 had a statistically significant greater incidence of unilateral and bilateral tears. Advancing age is believed to alter and change the intrinsic properties of the tendon leading to stiffness, hypovascularity and overall impairment of the biology of tendon healing. Furthermore, when repairs fail, they typically do so within the first four months of surgery. Means, therefore, to enhance the zone of the repair by increasing the cellularity immediately following surgery may improve the overall healing and lessen failures. Recently, nanofiber scaffolds have demonstrated the ability to mimic the extracellular matrix and help structure, organize, and proliferate cellular material. They do so by working, in essence, like a sponge when incorporated into the repair site, helping to bind, organize, and promote cell migration. This in effect, creates a less haphazard arrangement and induces better organization of healing tissue at the cellular level. Rotium, is an FDA-approved, nonwoven, microfiber matrix composed of PLCL (poly L-lactide-co-caprolactone) and PGL (polyglycolide) that is indicated for use in rotator cuff repair to enhance healing at the bone tendon interface. The implant is inserted under the rotator cuff tendon and placed on top of the greater tuberosity at the time of surgery and typically positioned over a suture. In a recent animal study performed at Colorado State University, a nearly 75% increased strength of repair was demonstrated at twelve weeks in those tendons treated with the graft. This will be the first prospective randomized clinical study in humans assessing for a difference in healing and strength in a population of patients considered at high risk for postoperative failure of the repair.
- STUDY OBJECTIVES
Utilizing a randomized controlled trial, this study seeks to evaluate if there is a difference in post-operative healing, strength, and functional outcomes in patients older than 55 years with rotator cuff tears treated with and without the nanofiber scaffold.
- Being tested
- nanofiber scaffold
- Keywords
- healing, regenerative medicine, interpositional matrix, synthetic scaffold, full-thickness rotator cuff tear, enthesis regeneration
- 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.
nanofiber scaffoldDevice
Also called ROTIUM™ Bioresorbable Wick (Atreon Orthopedics)
Utilization of the interpositional nanofiber scaffold to augment the rotator cuff repair.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Control | No intervention | Group 1 will serve as the control and undergo routine rotator cuff repair with suture anchors without the nanofiber scaffold. |
| Group 2 Scaffold | Active comparator | Group 2 will undergo rotator cuff repair with suture anchors and incorporation of the nanofiber scaffold. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of the repair
To determine if the use of the nanofiber scaffold changes the occurrence of postoperative rotator cuff repair (RCR) failure in patients older than 55 years
Measured: 24 months
Secondary outcomes (6)
Change in shoulder range of motion
Patients range of motion including forward flexion, abduction and external rotation will be measured preopertively and postoperatively with a manual goniometer at 6 weeks, 3 months, 6 months, 12 months and 24 months postoperatively to measure for differences.
Measured: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Change in isometric rotator cuff muscle strength peak force
To determine if the use of the nanofiber scaffold changes postoperative isometric muscle strength following RCR using a Lafayette muscle dynometer. The contralateral shoulder will be assessed for comparison. Measurements will be recorded in peak force and pounds of force.
Measured: Preoperative, 3 months, 6 months, 12 months, 24 months postoperative
Change in patient-reported American Shoulder and Elbow Scores
To determine if there is a difference in American Shoulder and Elbow scores of patients with rotator cuff tears treated with and without the nanofiber scaffold measured at preoperative visit, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery.
Measured: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Change in patient-reported postoperative pain (Visual Analogue Scale - Pain)
Patient reported postoperative visual analogue pain (on a scale of 0-10), measured preoperatively and postoperatively will be assessed for a difference. Pain scores will be checked at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery.
Measured: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Change in patient-reported Single Assessment Numeric Evaluation (SANE) score
Patient reported SANE score (on a scale of 0 to 100%), measured preoperatively and postoperatively will be assessed for a difference; Scores will be checked at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery.
Measured: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Change in patient-reported Veteran Rand 12 (VR-12) score
Patient reported VR-12 (Veteran rand) will be compared measured postoperatively will be assessed for a difference; Scores will be checked at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery.
Measured: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start29 Jun 2020
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Use of the nanofiber scaffold, in addition to SOC, during the rotator cuff repair is the intervention in this study. Study participants will be randomized into either the treatment or the control group. The control group will undergo routine rotator cuff repair without the scaffold to determine if improved healing is demonstrated with the graft. Group 1 (control) Group 2 (nanofiber scaffold)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atreon Orthopedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian L Badman, MD, Principal investigator, Central Indiana OrthopedicsElsa I Englund Kayuha, MD, Study director, Atreon Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325789
- Sponsor's protocol ID
- AO20200427
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mather RC 3rd, Koenig L, Acevedo D, Dall TM, Gallo P, Romeo A, Tongue J, Williams G Jr. The societal and economic value of rotator cuff repair. J Bone Joint Surg Am. 2013 Nov 20;95(22):1993-2000. doi: 10.2106/JBJS.L.01495.
PubMed 24257656Harryman DT 2nd, Hettrich CM, Smith KL, Campbell B, Sidles JA, Matsen FA 3rd. A prospective multipractice investigation of patients with full-thickness rotator cuff tears: the importance of comorbidities, practice, and other covariables on self-assessed shoulder function and health status. J Bone Joint Surg Am. 2003 Apr;85(4):690-6.
PubMed 12672846Iannotti JP, Deutsch A, Green A, Rudicel S, Christensen J, Marraffino S, Rodeo S. Time to failure after rotator cuff repair: a prospective imaging study. J Bone Joint Surg Am. 2013 Jun 5;95(11):965-71. doi: 10.2106/JBJS.L.00708.
PubMed 23780533Agudelo-Garcia PA, De Jesus JK, Williams SP, Nowicki MO, Chiocca EA, Liyanarachchi S, Li PK, Lannutti JJ, Johnson JK, Lawler SE, Viapiano MS. Glioma cell migration on three-dimensional nanofiber scaffolds is regulated by substrate topography and abolished by inhibition of STAT3 signaling. Neoplasia. 2011 Sep;13(9):831-40. doi: 10.1593/neo.11612.
PubMed 21969816Teunis T, Lubberts B, Reilly BT, Ring D. A systematic review and pooled analysis of the prevalence of rotator cuff disease with increasing age. J Shoulder Elbow Surg. 2014 Dec;23(12):1913-1921. doi: 10.1016/j.jse.2014.08.001.
PubMed 25441568Le BT, Wu XL, Lam PH, Murrell GA. Factors predicting rotator cuff retears: an analysis of 1000 consecutive rotator cuff repairs. Am J Sports Med. 2014 May;42(5):1134-42. doi: 10.1177/0363546514525336. Epub 2014 Apr 18.
PubMed 24748610Diebold G, Lam P, Walton J, Murrell GAC. Relationship Between Age and Rotator Cuff Retear: A Study of 1,600 Consecutive Rotator Cuff Repairs. J Bone Joint Surg Am. 2017 Jul 19;99(14):1198-1205. doi: 10.2106/JBJS.16.00770.
PubMed 28719559Gulotta LV, Nho SJ, Dodson CC, Adler RS, Altchek DW, MacGillivray JD; HSS Arthroscopic Rotator Cuff Registry. Prospective evaluation of arthroscopic rotator cuff repairs at 5 years: part II--prognostic factors for clinical and radiographic outcomes. J Shoulder Elbow Surg. 2011 Sep;20(6):941-6. doi: 10.1016/j.jse.2011.03.028. Epub 2011 Jun 29.
PubMed 21719319Liem D, Lichtenberg S, Magosch P, Habermeyer P. Magnetic resonance imaging of arthroscopic supraspinatus tendon repair. J Bone Joint Surg Am. 2007 Aug;89(8):1770-6. doi: 10.2106/JBJS.F.00749.
PubMed 17671017Koh KH, Kang KC, Lim TK, Shon MS, Yoo JC. Prospective randomized clinical trial of single- versus double-row suture anchor repair in 2- to 4-cm rotator cuff tears: clinical and magnetic resonance imaging results. Arthroscopy. 2011 Apr;27(4):453-62. doi: 10.1016/j.arthro.2010.11.059.
PubMed 21444007Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.
PubMed 15930531Tempelhof S, Rupp S, Seil R. Age-related prevalence of rotator cuff tears in asymptomatic shoulders. J Shoulder Elbow Surg. 1999 Jul-Aug;8(4):296-9. doi: 10.1016/s1058-2746(99)90148-9.
PubMed 10471998Bishop J, Klepps S, Lo IK, Bird J, Gladstone JN, Flatow EL. Cuff integrity after arthroscopic versus open rotator cuff repair: a prospective study. J Shoulder Elbow Surg. 2006 May-Jun;15(3):290-9. doi: 10.1016/j.jse.2005.09.017.
PubMed 16679227Tashjian RZ, Hollins AM, Kim HM, Teefey SA, Middleton WD, Steger-May K, Galatz LM, Yamaguchi K. Factors affecting healing rates after arthroscopic double-row rotator cuff repair. Am J Sports Med. 2010 Dec;38(12):2435-42. doi: 10.1177/0363546510382835. Epub 2010 Oct 28.
PubMed 21030564Thomazeau H, Boukobza E, Morcet N, Chaperon J, Langlais F. Prediction of rotator cuff repair results by magnetic resonance imaging. Clin Orthop Relat Res. 1997 Nov;(344):275-83.
PubMed 9372778
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicenter Evaluation of Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years
- ClinicalTrials.gov ID
- NCT04325789
- Acronym / sponsor ID
- AO20200427
- Keywords
- healing, regenerative medicine, interpositional matrix, synthetic scaffold, full-thickness rotator cuff tear, enthesis regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Atreon OrthopedicsIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 30 Mar 2020 (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.
Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.
Detailed description
- INTRODUCTION This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures. Despite numerous advancements in surgical techniques and over 250,000 procedures currently performed annually in the United States, failure of tendon healing following rotator cuff surgery occurs frequently with reports as high as 94%. Nonhealing can lead to persistent pain, poor outcomes, and a significant economic burden to society when revision surgery is required. Several factors have been associated with poor tendon healing with age greater than 60 years shown to be a significant risk factor due to diminishing vascularity at the bone tendon interface where the tear typically originates. While numerous techniques have been devised to improve fixation over the past several decades, very few have been developed to address or enhance the biology at the repair site. Rotium nanofiber is a recent FDA approved scaffold (FDA 510(K) #K183236) that has been shown to improve tendon healing to bone in animal studies. It works to mimic the extracellular matrix and helps concentrates and bind cells at the repair site providing a better organizational structure of the healing tissue. The purpose of the current study is to assess if use of the scaffold significantly improves rotator cuff healing and enhances strength in patients at higher risk of perioperative failure of the repair.
- BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE Rotator cuff tears are a frequent cause of shoulder pain and disability in the elderly population. Typically, when conservative measures fail, surgery is often advised. A successful clinical outcome is felt to be heavily predicated on healing of the tendon to the bone. Despite numerous surgical and technical advancements over the past two decades not all repairs heal, with re-tear, or failure-to-heal, remaining the number one complication associated with rotator cuff surgery. This in turn creates a hefty economic burden on society whereupon surgeries are being performed with poor eventual outcomes and ultimately wasted resources. While reasons for failure are multifactorial, a strong correlation has been associated with advancing age. In an observational study on the natural history of rotator cuff disease, patients younger than 50 years old rarely had rotator cuff tears whereas those greater than 60 had a statistically significant greater incidence of unilateral and bilateral tears. Advancing age is believed to alter and change the intrinsic properties of the tendon leading to stiffness, hypovascularity and overall impairment of the biology of tendon healing. Furthermore, when repairs fail, they typically do so within the first four months of surgery. Means, therefore, to enhance the zone of the repair by increasing the cellularity immediately following surgery may improve the overall healing and lessen failures. Recently, nanofiber scaffolds have demonstrated the ability to mimic the extracellular matrix and help structure, organize, and proliferate cellular material. They do so by working, in essence, like a sponge when incorporated into the repair site, helping to bind, organize, and promote cell migration. This in effect, creates a less haphazard arrangement and induces better organization of healing tissue at the cellular level. Rotium, is an FDA-approved, nonwoven, microfiber matrix composed of PLCL (poly L-lactide-co-caprolactone) and PGL (polyglycolide) that is indicated for use in rotator cuff repair to enhance healing at the bone tendon interface. The implant is inserted under the rotator cuff tendon and placed on top of the greater tuberosity at the time of surgery and typically positioned over a suture. In a recent animal study performed at Colorado State University, a nearly 75% increased strength of repair was demonstrated at twelve weeks in those tendons treated with the graft. This will be the first prospective randomized clinical study in humans assessing for a difference in healing and strength in a population of patients considered at high risk for postoperative failure of the repair.
- STUDY OBJECTIVES
Utilizing a randomized controlled trial, this study seeks to evaluate if there is a difference in post-operative healing, strength, and functional outcomes in patients older than 55 years with rotator cuff tears treated with and without the nanofiber scaffold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Use of the nanofiber scaffold, in addition to SOC, during the rotator cuff repair is the intervention in this study. Study participants will be randomized into either the treatment or the control group. The control group will undergo routine rotator cuff repair without the scaffold to determine if improved healing is demonstrated with the graft. Group 1 (control) Group 2 (nanofiber scaffold)
| Arm | Type | Receives |
|---|---|---|
| Group 1 Control | No intervention | –Group 1 will serve as the control and undergo routine rotator cuff repair with suture anchors without the nanofiber scaffold. |
| Group 2 Scaffold | Active comparator | –Group 2 will undergo rotator cuff repair with suture anchors and incorporation of the nanofiber scaffold. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 55 and older
- Able to provide informed consent
- Primary diagnosis of rotator cuff tear
Key exclusion criteria (4 listed)
- Revision rotator cuff surgery
- Partial thickness rotator cuff tears
- Massive (greater than 5cm) rotator cuff tears
- Patients with current tobacco history
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 |
|---|---|---|
| nanofiber scaffoldAlso: ROTIUM™ Bioresorbable Wick (Atreon Orthopedics)Utilization of the interpositional nanofiber scaffold to augment the rotator cuff repair. | Device | – |
Primary outcome
Failure of the repair
Time frame: 24 months
To determine if the use of the nanofiber scaffold changes the occurrence of postoperative rotator cuff repair (RCR) failure in patients older than 55 years
6 secondary outcomes
Change in shoulder range of motion
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Change in isometric rotator cuff muscle strength peak force
Time frame: Preoperative, 3 months, 6 months, 12 months, 24 months postoperative
Change in patient-reported American Shoulder and Elbow Scores
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Change in patient-reported postoperative pain (Visual Analogue Scale - Pain)
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Change in patient-reported Single Assessment Numeric Evaluation (SANE) score
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Change in patient-reported Veteran Rand 12 (VR-12) score
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 24257656Mather RC 3rd, Koenig L, Acevedo D, Dall TM, Gallo P, Romeo A, Tongue J, Williams G Jr. The societal and economic value of rotator cuff repair. J Bone Joint Surg Am. 2013 Nov 20;95(22):1993-2000. doi: 10.2106/JBJS.L.01495.
- Background: PubMed 12672846Harryman DT 2nd, Hettrich CM, Smith KL, Campbell B, Sidles JA, Matsen FA 3rd. A prospective multipractice investigation of patients with full-thickness rotator cuff tears: the importance of comorbidities, practice, and other covariables on self-assessed shoulder function and health status. J Bone Joint Surg Am. 2003 Apr;85(4):690-6.
- Background: PubMed 23780533Iannotti JP, Deutsch A, Green A, Rudicel S, Christensen J, Marraffino S, Rodeo S. Time to failure after rotator cuff repair: a prospective imaging study. J Bone Joint Surg Am. 2013 Jun 5;95(11):965-71. doi: 10.2106/JBJS.L.00708.
- Background: PubMed 21969816Agudelo-Garcia PA, De Jesus JK, Williams SP, Nowicki MO, Chiocca EA, Liyanarachchi S, Li PK, Lannutti JJ, Johnson JK, Lawler SE, Viapiano MS. Glioma cell migration on three-dimensional nanofiber scaffolds is regulated by substrate topography and abolished by inhibition of STAT3 signaling. Neoplasia. 2011 Sep;13(9):831-40. doi: 10.1593/neo.11612.
- Background: PubMed 25441568Teunis T, Lubberts B, Reilly BT, Ring D. A systematic review and pooled analysis of the prevalence of rotator cuff disease with increasing age. J Shoulder Elbow Surg. 2014 Dec;23(12):1913-1921. doi: 10.1016/j.jse.2014.08.001.
- Background: PubMed 24748610Le BT, Wu XL, Lam PH, Murrell GA. Factors predicting rotator cuff retears: an analysis of 1000 consecutive rotator cuff repairs. Am J Sports Med. 2014 May;42(5):1134-42. doi: 10.1177/0363546514525336. Epub 2014 Apr 18.
- Background: PubMed 28719559Diebold G, Lam P, Walton J, Murrell GAC. Relationship Between Age and Rotator Cuff Retear: A Study of 1,600 Consecutive Rotator Cuff Repairs. J Bone Joint Surg Am. 2017 Jul 19;99(14):1198-1205. doi: 10.2106/JBJS.16.00770.
- Background: PubMed 21719319Gulotta LV, Nho SJ, Dodson CC, Adler RS, Altchek DW, MacGillivray JD; HSS Arthroscopic Rotator Cuff Registry. Prospective evaluation of arthroscopic rotator cuff repairs at 5 years: part II--prognostic factors for clinical and radiographic outcomes. J Shoulder Elbow Surg. 2011 Sep;20(6):941-6. doi: 10.1016/j.jse.2011.03.028. Epub 2011 Jun 29.
- Background: PubMed 17671017Liem D, Lichtenberg S, Magosch P, Habermeyer P. Magnetic resonance imaging of arthroscopic supraspinatus tendon repair. J Bone Joint Surg Am. 2007 Aug;89(8):1770-6. doi: 10.2106/JBJS.F.00749.
- Background: PubMed 21444007Koh KH, Kang KC, Lim TK, Shon MS, Yoo JC. Prospective randomized clinical trial of single- versus double-row suture anchor repair in 2- to 4-cm rotator cuff tears: clinical and magnetic resonance imaging results. Arthroscopy. 2011 Apr;27(4):453-62. doi: 10.1016/j.arthro.2010.11.059.
- Background: PubMed 15930531Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.
- Background: PubMed 10471998Tempelhof S, Rupp S, Seil R. Age-related prevalence of rotator cuff tears in asymptomatic shoulders. J Shoulder Elbow Surg. 1999 Jul-Aug;8(4):296-9. doi: 10.1016/s1058-2746(99)90148-9.
- Individual participant dataSharing planned: No
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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.
Brian L Badman, MD principal investigator
Central Indiana Orthopedics
Elsa I Englund Kayuha, MD study director
Atreon Orthopedics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nanofiber scaffold in people with Rotator Cuff Tears and Full-thickness Rotator Cuff Tears, run by Atreon Orthopedics at 4 sites in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of the repair (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04325789, which also lists 38 linked publications.
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 29 Apr 2026.