Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years
NCT ID: NCT04325789
Last Updated: 2025-01-23
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
91 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-06-29
Study Completion Date
2025-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcomes in Rotator Cuff Repair Using Graft Reinforcement
NCT01025037
Rotator Cuff Tear
COMPLETED
NA
Clinical Trial on the Effect of the Flexible Suturing System With Anchors (FSSA) in Full-thickness Rotator Cuff Tendon Tears
NCT06868108
Rotator Cuff Tears
ENROLLING_BY_INVITATION
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
NCT05981833
Full-thickness Rotator Cuff Tear
RECRUITING
Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique
NCT02256891
Rotator Cuff Tear
COMPLETED
PHASE4
Rotator Cuff Repair With Arthroscopic Acromioplasty (Shaving the Acromion Bone) Versus Repair Without Acromioplasty
NCT00664794
Shoulder Injuries
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. 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.
2. 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.
3. 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.
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.
2. 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.
3. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Rotator Cuff Tears
Full-thickness Rotator Cuff Tears
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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)
Group 1 (control) Group 2 (nanofiber scaffold)
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
This is a single blinded study. The patient will be blinded to the treatment group.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 Control
Group 1 will serve as the control and undergo routine rotator cuff repair with suture anchors without the nanofiber scaffold.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Group 2 Scaffold
Group 2 will undergo rotator cuff repair with suture anchors and incorporation of the nanofiber scaffold.
Group Type
ACTIVE_COMPARATOR
nanofiber scaffold
Intervention Type
DEVICE
Utilization of the interpositional nanofiber scaffold to augment the rotator cuff repair.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
nanofiber scaffold
Utilization of the interpositional nanofiber scaffold to augment the rotator cuff repair.
Intervention Type
DEVICE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
ROTIUM™ Bioresorbable Wick (Atreon Orthopedics)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Age 55 and older
2. Able to provide informed consent
3. Primary diagnosis of rotator cuff tear
2. Able to provide informed consent
3. Primary diagnosis of rotator cuff tear
Exclusion Criteria
1. Revision rotator cuff surgery
2. Partial thickness rotator cuff tears
3. Massive (greater than 5cm) rotator cuff tears
4. Patients with current tobacco history
2. Partial thickness rotator cuff tears
3. Massive (greater than 5cm) rotator cuff tears
4. Patients with current tobacco history
Minimum Eligible Age
55 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Atreon Orthopedics
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brian L Badman, MD
Role: PRINCIPAL_INVESTIGATOR
Central Indiana Orthopedics
Elsa I Englund Kayuha, MD
Role: STUDY_DIRECTOR
Atreon Orthopedics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central Indiana Orthopedics
Fishers, Indiana, United States
Site Status
Associated Orthopedists of Detroit
Saint Clair Shores, Michigan, United States
Site Status
The Christ Hospital & The Lindner Reseach Center at The Christ Hospital
Cincinnati, Ohio, United States
Site Status
Steadman Hawkins Clinic of the Carolinas - Patewood
Greenville, South Carolina, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
Harryman 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.
Reference Type
BACKGROUND
Iannotti 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.
Reference Type
BACKGROUND
Agudelo-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.
Reference Type
BACKGROUND
Teunis 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.
Reference Type
BACKGROUND
Le 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.
Reference Type
BACKGROUND
Diebold 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.
Reference Type
BACKGROUND
Gulotta 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.
Reference Type
BACKGROUND
Liem 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.
Reference Type
BACKGROUND
Koh 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.
Reference Type
BACKGROUND
Boileau 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.
Reference Type
BACKGROUND
Tempelhof 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.
Reference Type
BACKGROUND
Bishop 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.
Reference Type
BACKGROUND
Tashjian 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.
Reference Type
BACKGROUND
Thomazeau 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.
Reference Type
BACKGROUND
Kim KC, Shin HD, Lee WY. Repair integrity and functional outcomes after arthroscopic suture-bridge rotator cuff repair. J Bone Joint Surg Am. 2012 Apr 18;94(8):e48. doi: 10.2106/JBJS.K.00158.
Reference Type
BACKGROUND
Boehm TD, Werner A, Radtke S, Mueller T, Kirschner S, Gohlke F. The effect of suture materials and techniques on the outcome of repair of the rotator cuff: a prospective, randomised study. J Bone Joint Surg Br. 2005 Jun;87(6):819-23. doi: 10.1302/0301-620X.87B6.15638.
Reference Type
BACKGROUND
Charousset C, Grimberg J, Duranthon LD, Bellaiche L, Petrover D. Can a double-row anchorage technique improve tendon healing in arthroscopic rotator cuff repair?: A prospective, nonrandomized, comparative study of double-row and single-row anchorage techniques with computed tomographic arthrography tendon healing assessment. Am J Sports Med. 2007 Aug;35(8):1247-53. doi: 10.1177/0363546507301661. Epub 2007 Apr 23.
Reference Type
BACKGROUND
Deutsch A, Kroll DG, Hasapes J, Staewen RS, Pham C, Tait C. Repair integrity and clinical outcome after arthroscopic rotator cuff repair using single-row anchor fixation: a prospective study of single-tendon and two-tendon tears. J Shoulder Elbow Surg. 2008 Nov-Dec;17(6):845-52. doi: 10.1016/j.jse.2008.04.004. Epub 2008 Aug 20.
Reference Type
BACKGROUND
Franceschi F, Ruzzini L, Longo UG, Martina FM, Zobel BB, Maffulli N, Denaro V. Equivalent clinical results of arthroscopic single-row and double-row suture anchor repair for rotator cuff tears: a randomized controlled trial. Am J Sports Med. 2007 Aug;35(8):1254-60. doi: 10.1177/0363546507302218. Epub 2007 Jun 6.
Reference Type
BACKGROUND
Klepps S, Bishop J, Lin J, Cahlon O, Strauss A, Hayes P, Flatow EL. Prospective evaluation of the effect of rotator cuff integrity on the outcome of open rotator cuff repairs. Am J Sports Med. 2004 Oct-Nov;32(7):1716-22. doi: 10.1177/0363546504265262.
Reference Type
BACKGROUND
Ko SH, Lee CC, Friedman D, Park KB, Warner JJ. Arthroscopic single-row supraspinatus tendon repair with a modified mattress locking stitch: a prospective, randomized controlled comparison with a simple stitch. Arthroscopy. 2008 Sep;24(9):1005-12. doi: 10.1016/j.arthro.2008.04.074. Epub 2008 Jun 24.
Reference Type
BACKGROUND
Lapner PL, Sabri E, Rakhra K, McRae S, Leiter J, Bell K, Macdonald P. A multicenter randomized controlled trial comparing single-row with double-row fixation in arthroscopic rotator cuff repair. J Bone Joint Surg Am. 2012 Jul 18;94(14):1249-57. doi: 10.2106/JBJS.K.00999.
Reference Type
BACKGROUND
Lee BG, Cho NS, Rhee YG. Effect of two rehabilitation protocols on range of motion and healing rates after arthroscopic rotator cuff repair: aggressive versus limited early passive exercises. Arthroscopy. 2012 Jan;28(1):34-42. doi: 10.1016/j.arthro.2011.07.012. Epub 2011 Oct 20.
Reference Type
BACKGROUND
Ma HL, Chiang ER, Wu HT, Hung SC, Wang ST, Liu CL, Chen TH. Clinical outcome and imaging of arthroscopic single-row and double-row rotator cuff repair: a prospective randomized trial. Arthroscopy. 2012 Jan;28(1):16-24. doi: 10.1016/j.arthro.2011.07.003. Epub 2011 Oct 7.
Reference Type
BACKGROUND
Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004 Feb;86(2):219-24. doi: 10.2106/00004623-200402000-00002.
Reference Type
BACKGROUND
Jost B, Pfirrmann CW, Gerber C, Switzerland Z. Clinical outcome after structural failure of rotator cuff repairs. J Bone Joint Surg Am. 2000 Mar;82(3):304-14. doi: 10.2106/00004623-200003000-00002.
Reference Type
BACKGROUND
Liu SH, Baker CL. Arthroscopically assisted rotator cuff repair: correlation of functional results with integrity of the cuff. Arthroscopy. 1994 Feb;10(1):54-60. doi: 10.1016/s0749-8063(05)80293-2.
Reference Type
BACKGROUND
Akpinar S, Uysal M, Pourbagher MA, Ozalay M, Cesur N, Hersekli MA. Prospective evaluation of the functional and anatomical results of arthroscopic repair in small and medium-sized full-thickness tears of the supraspinatus tendon. Acta Orthop Traumatol Turc. 2011;45(4):248-53. doi: 10.3944/AOTT.2011.2455.
Reference Type
BACKGROUND
Harryman DT 2nd, Mack LA, Wang KY, Jackins SE, Richardson ML, Matsen FA 3rd. Repairs of the rotator cuff. Correlation of functional results with integrity of the cuff. J Bone Joint Surg Am. 1991 Aug;73(7):982-9.
Reference Type
BACKGROUND
Mall NA, Kim HM, Keener JD, Steger-May K, Teefey SA, Middleton WD, Stobbs G, Yamaguchi K. Symptomatic progression of asymptomatic rotator cuff tears: a prospective study of clinical and sonographic variables. J Bone Joint Surg Am. 2010 Nov 17;92(16):2623-33. doi: 10.2106/JBJS.I.00506.
Reference Type
BACKGROUND
Yamaguchi K, Ditsios K, Middleton WD, Hildebolt CF, Galatz LM, Teefey SA. The demographic and morphological features of rotator cuff disease. A comparison of asymptomatic and symptomatic shoulders. J Bone Joint Surg Am. 2006 Aug;88(8):1699-704. doi: 10.2106/JBJS.E.00835.
Reference Type
BACKGROUND
Cho NS, Rhee YG. The factors affecting the clinical outcome and integrity of arthroscopically repaired rotator cuff tears of the shoulder. Clin Orthop Surg. 2009 Jun;1(2):96-104. doi: 10.4055/cios.2009.1.2.96. Epub 2009 May 30.
Reference Type
BACKGROUND
Nho SJ, Shindle MK, Adler RS, Warren RF, Altchek DW, MacGillivray JD. Prospective analysis of arthroscopic rotator cuff repair: subgroup analysis. J Shoulder Elbow Surg. 2009 Sep-Oct;18(5):697-704. doi: 10.1016/j.jse.2008.11.018. Epub 2009 Mar 9.
Reference Type
BACKGROUND
Hein J, Reilly JM, Chae J, Maerz T, Anderson K. Retear Rates After Arthroscopic Single-Row, Double-Row, and Suture Bridge Rotator Cuff Repair at a Minimum of 1 Year of Imaging Follow-up: A Systematic Review. Arthroscopy. 2015 Nov;31(11):2274-81. doi: 10.1016/j.arthro.2015.06.004. Epub 2015 Jul 15.
Reference Type
BACKGROUND
Fukunishi T, Best CA, Ong CS, Groehl T, Reinhardt J, Yi T, Miyachi H, Zhang H, Shinoka T, Breuer CK, Johnson J, Hibino N. Role of Bone Marrow Mononuclear Cell Seeding for Nanofiber Vascular Grafts. Tissue Eng Part A. 2018 Jan;24(1-2):135-144. doi: 10.1089/ten.TEA.2017.0044. Epub 2017 Jun 13.
Reference Type
BACKGROUND
Fukunishi T, Best CA, Sugiura T, Opfermann J, Ong CS, Shinoka T, Breuer CK, Krieger A, Johnson J, Hibino N. Preclinical study of patient-specific cell-free nanofiber tissue-engineered vascular grafts using 3-dimensional printing in a sheep model. J Thorac Cardiovasc Surg. 2017 Apr;153(4):924-932. doi: 10.1016/j.jtcvs.2016.10.066. Epub 2016 Nov 14.
Reference Type
BACKGROUND
Romeo A, Easley J, Regan D, Hackett E, Johnson J, Johnson J, Puttlitz C, McGilvray K. Rotator cuff repair using a bioresorbable nanofiber interposition scaffold: a biomechanical and histologic analysis in sheep. J Shoulder Elbow Surg. 2022 Feb;31(2):402-412. doi: 10.1016/j.jse.2021.07.018. Epub 2021 Aug 25.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AO20200427
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair
NCT02915588
COMPLETED
NA
Use of Graft Jacket for Rotator Cuff Repair
NCT00456781
COMPLETED
NA
Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
NCT03295994
COMPLETED
NA
Lower Trapezius Transfer vs Bridging Reconstruction
NCT05925881
RECRUITING
NA
Demineralized Bone Matrix Rotator Cuff Study
NCT04686396
UNKNOWN
NA
Operative Versus Non-operative Management of Rotator Cuff Tear
NCT00695981
ACTIVE_NOT_RECRUITING
NA
Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair
NCT04673344
UNKNOWN
NA
Microfracture in Rotator Cuff Injury Repair
NCT02097901
SUSPENDED
NA
The Effects of Platelet Rich Plasma on the Integrity of Rotator Cuff Repair
NCT01424969
COMPLETED
Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair
NCT03797287
WITHDRAWN
NA
Acellular Dermis in Rotator Cuff Repair
NCT05458349
COMPLETED
NA
Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears
NCT00762580
COMPLETED
FiberLocker® System Augmentation of Rotator Cuff Repairs
NCT06918041
RECRUITING
NA
Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot
NCT03577379
COMPLETED
NA
Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
NCT05894265
RECRUITING
NA
Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
NCT03752034
RECRUITING
NA
Cohort of Patients With a Symptomatic Rotator Cuff Tear Treated Without Surgical Repair
NCT02510352
COMPLETED
Arthroscopic Repair of Partial Thickness Articular-Side Rotator Cuff Tears: Transtendon Versus Conversion Repair Techniques
NCT07289659
COMPLETED
NA
Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)
NCT06505135
ENROLLING_BY_INVITATION
PHASE1
Biomodulating Rotator Cuff Healing - A Proof of Concept Trial
NCT04618484
UNKNOWN
NA
Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
NCT00290888
COMPLETED
NA
Early Mobilization Following Mini-Open Rotator Cuff Repair
NCT01741272
COMPLETED
PHASE4
Treatment of Rotator Cuff Tears With Platelet Rich Plasma
NCT06481046
WITHDRAWN
NA
The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair
NCT02050087
COMPLETED
NA
Arthroscopic Rotator Cuff Repair: Suture Anchors Versus Arthroscopic Transosseous Fixation
NCT01815177
COMPLETED
NA