Study Summary
This trial is to see if the ArthroFLEX® ECM scaffold graph can help reduce the failure rate for large and massive rotator cuff tears.
Eligible Conditions
- Rotator Cuff Tears
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: As assessed at 1 year postoperatively.
Year 1
Comparison of healing by MRI vs US
Tendon healing
Year 1
Progress of tendon healing
Year 1
Patient Outcomes: Constant Score (CS)
Shoulder
Patient Outcomes: Subjective Shoulder Value (SSV)
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)
Erythrocyte Indices
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Control Group
1 of 2
Treatment Group
1 of 2
Active Control
70 Total Participants · 2 Treatment Groups
Primary Treatment: Treatment Group · No Placebo Group · Phase 4
Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:
Treatment GroupActiveComparator Group · 2 Interventions: ArthroFLEX ECM scaffold graft, Control · Intervention Types: Biological, Procedure
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: as assessed at 1 year postoperatively.
Who is running the clinical trial?
Gregory GilotLead Sponsor
LifeNet HealthIndustry Sponsor
11 Previous Clinical Trials
1,058 Total Patients Enrolled
The Cleveland ClinicOTHER
959 Previous Clinical Trials
1,363,993 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
175 Patients Enrolled for Rotator Cuff Tears
Gregory J Gilot, MDPrincipal InvestigatorCleveland Clinic Florida
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are eligible for RCR surgery.
References
- Derwin KA, Badylak SF, Steinmann SP, Iannotti JP. Extracellular matrix scaffold devices for rotator cuff repair. J Shoulder Elbow Surg. 2010 Apr;19(3):467-76. doi: 10.1016/j.jse.2009.10.020. Epub 2010 Feb 26.
- Zheng MH, Chen J, Kirilak Y, Willers C, Xu J, Wood D. Porcine small intestine submucosa (SIS) is not an acellular collagenous matrix and contains porcine DNA: possible implications in human implantation. J Biomed Mater Res B Appl Biomater. 2005 Apr;73(1):61-7.
- Badylak SF, Freytes DO, Gilbert TW. Extracellular matrix as a biological scaffold material: Structure and function. Acta Biomater. 2009 Jan;5(1):1-13. doi: 10.1016/j.actbio.2008.09.013. Epub 2008 Oct 2. Review.
- Iannotti JP, Codsi MJ, Kwon YW, Derwin K, Ciccone J, Brems JJ. Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears. A randomized, controlled trial. J Bone Joint Surg Am. 2006 Jun;88(6):1238-44.
- Walton JR, Bowman NK, Khatib Y, Linklater J, Murrell GA. Restore orthobiologic implant: not recommended for augmentation of rotator cuff repairs. J Bone Joint Surg Am. 2007 Apr;89(4):786-91.
- Bond JL, Dopirak RM, Higgins J, Burns J, Snyder SJ. Arthroscopic replacement of massive, irreparable rotator cuff tears using a GraftJacket allograft: technique and preliminary results. Arthroscopy. 2008 Apr;24(4):403-409.e1. doi: 10.1016/j.arthro.2007.07.033.
- Sclamberg SG, Tibone JE, Itamura JM, Kasraeian S. Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced with porcine small intestinal submucosa. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):538-41.
- Parnes N, Bartoszewski NR, Defranco MJ. Arthroscopic Repair of Full-Thickness Rotator Cuff Tears in Active Patients Younger Than 40 Years: 2- to 5-Year Clinical Outcomes. Orthopedics. 2018 Jan 1;41(1):e52-e57. doi: 10.3928/01477447-20171114-02. Epub 2017 Nov 21.
- Schlegel TF, Hawkins RJ, Lewis CW, Motta T, Turner AS. The effects of augmentation with Swine small intestine submucosa on tendon healing under tension: histologic and mechanical evaluations in sheep. Am J Sports Med. 2006 Feb;34(2):275-80. Epub 2005 Oct 6.
- Greenspoon JA, Petri M, Warth RJ, Millett PJ. Massive rotator cuff tears: pathomechanics, current treatment options, and clinical outcomes. J Shoulder Elbow Surg. 2015 Sep;24(9):1493-505. doi: 10.1016/j.jse.2015.04.005. Epub 2015 Jun 28. Review.
- Badhe SP, Lawrence TM, Smith FD, Lunn PG. An assessment of porcine dermal xenograft as an augmentation graft in the treatment of extensive rotator cuff tears. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):35S-39S. doi: 10.1016/j.jse.2007.08.005.
- Soler JA, Gidwani S, Curtis MJ. Early complications from the use of porcine dermal collagen implants (Permacol) as bridging constructs in the repair of massive rotator cuff tears. A report of 4 cases. Acta Orthop Belg. 2007 Aug;73(4):432-6.
- Chung SW, Kim JY, Kim MH, Kim SH, Oh JH. Arthroscopic repair of massive rotator cuff tears: outcome and analysis of factors associated with healing failure or poor postoperative function. Am J Sports Med. 2013 Jul;41(7):1674-83. doi: 10.1177/0363546513485719. Epub 2013 Apr 30.
- Brophy RH, Beauvais RL, Jones EC, Cordasco FA, Marx RG. Measurement of shoulder activity level. Clin Orthop Relat Res. 2005 Oct;439:101-8.
- Brophy RH, Beauvais RL, Jones EC, Cordasco FA, Marx RG. Measurement of shoulder activity level. Clin Orthop Relat Res. 2005 Oct;439:101-8. doi: 10.1097/01.blo.0000173255.85016.1f.
- Iannotti JP, Codsi MJ, Kwon YW, Derwin K, Ciccone J, Brems JJ. Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears. A randomized, controlled trial. J Bone Joint Surg Am. 2006 Jun;88(6):1238-44. doi: 10.2106/JBJS.E.00524.
- Greenspoon JA, Petri M, Warth RJ, Millett PJ. Massive rotator cuff tears: pathomechanics, current treatment options, and clinical outcomes. J Shoulder Elbow Surg. 2015 Sep;24(9):1493-505. doi: 10.1016/j.jse.2015.04.005. Epub 2015 Jun 28.
- Zheng MH, Chen J, Kirilak Y, Willers C, Xu J, Wood D. Porcine small intestine submucosa (SIS) is not an acellular collagenous matrix and contains porcine DNA: possible implications in human implantation. J Biomed Mater Res B Appl Biomater. 2005 Apr;73(1):61-7. doi: 10.1002/jbm.b.30170.
- Badylak SF, Freytes DO, Gilbert TW. Extracellular matrix as a biological scaffold material: Structure and function. Acta Biomater. 2009 Jan;5(1):1-13. doi: 10.1016/j.actbio.2008.09.013. Epub 2008 Oct 2.
- Walton JR, Bowman NK, Khatib Y, Linklater J, Murrell GA. Restore orthobiologic implant: not recommended for augmentation of rotator cuff repairs. J Bone Joint Surg Am. 2007 Apr;89(4):786-91. doi: 10.2106/JBJS.F.00315.
- Sclamberg SG, Tibone JE, Itamura JM, Kasraeian S. Six-month magnetic resonance imaging follow-up of large and massive rotator cuff repairs reinforced with porcine small intestinal submucosa. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):538-41. doi: 10.1016/j.jse.2004.03.005.
- Schlegel TF, Hawkins RJ, Lewis CW, Motta T, Turner AS. The effects of augmentation with Swine small intestine submucosa on tendon healing under tension: histologic and mechanical evaluations in sheep. Am J Sports Med. 2006 Feb;34(2):275-80. doi: 10.1177/0363546505279912. Epub 2005 Oct 6.
- Gregory Gilot 2018. "LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03551509.
Frequently Asked Questions
Does Treatment Group have the official sanction of the FDA?
"The Treatment Group is deemed safe enough to warrant a score of 3, as it has been approved for use in Phase 4 trials." - Anonymous Online Contributor
Unverified Answer
What ailments does Treatment Group usually treat?
"Treatment Group is a viable option for managing symptoms of osteoarthritis, joint ache, and lower back discomfort." - Anonymous Online Contributor
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Is enrollment open for this medical experiment at present?
"The clinical trial's current status is recruiting, as per the information hosted on clinicaltrials.gov. The investigation was initially announced on 7/1/2018 and has been revised most recently on 10/13/2022." - Anonymous Online Contributor
Unverified Answer
What is the desired outcome of this research endeavor?
"According to LifeNet Health, the primary objective of this trial is tendon healing and will be measured post-operatively at 1 year. Additional secondary objectives include Patient Outcomes: Measurement of Shoulder Activity Level (a numerical sum of scores for five activities rated on a 5 point frequency scale), The American Shoulder and Elbow Surgeon Shoulder Score (ASES) which assesses range of motion, physical signs, strength, and stability), and Subjective Shoulder Value (SSV; patient's subjective assessment expressed as a % of an entirely normal shoulder)." - Anonymous Online Contributor
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How many participants are involved in the experiment?
"Affirmative. According to the records stored on clinicaltrials.gov, this trial is actively enrolling patients and has been since July 1st 2018. The last modification was made on October 13th 2022 with an aim of recruiting 70 individuals across a single site." - Anonymous Online Contributor
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