Clinical Trials Logo
  1. Home
  2. Rotator Cuff Tear
  3. NCT01122498

A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears

Rotator Cuff Tear Clinical Trial

Official title:
A Phase 1, Randomized, Open-Label, Standard Of Care Control, Dose-Escalating, Multicenter, Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Full-Thickness Rotator Cuff Tears Treated By Means Of An Open Surgical Repair

Clinical Trial Summary

Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria. At the time of open surgical repair, subjects who are randomized to receive the test article in addition to the Standard of Care (SOC) will be hospitalized and have a single dose of BMP-655/ACS surgically implanted at the site of tendon attachment to bone. Subjects who are randomized to receive SOC alone will receive no test article. Following surgery, subjects will be prescribed a rehabilitation plan. Subjects will then complete 9 follow-up visits beginning 24 hours after surgery and continuing through 52 weeks.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01122498
Study type Interventional
Source Pfizer
Contact
Status Terminated
Phase Phase 1
Start date June 2010
Completion date April 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT03663036 - Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Suspended NCT03290196 - The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics Phase 4
Active, not recruiting NCT03091075 - Oxandrolone Rotator Cuff Trial N/A
Completed NCT03380533 - Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair Phase 2/Phase 3
Completed NCT04566939 - A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
Active, not recruiting NCT02716441 - Rotator Cuff Failure With Continuity
Completed NCT03540030 - Opioid-Free Shoulder Arthroplasty Phase 4
Completed NCT02298023 - Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear) Phase 2
Completed NCT01459536 - Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear N/A
Completed NCT02850211 - A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair Phase 4
Completed NCT01383239 - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs N/A
Completed NCT01170312 - Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation N/A
Terminated NCT00936559 - Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair Phase 1
Completed NCT01204606 - Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA) N/A
Completed NCT00852657 - Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff N/A
Active, not recruiting NCT00182299 - An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS Phase 4
Recruiting NCT06120998 - Quality of Life After Arthroscopic Rotator Cuff Repair
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT02644564 - Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries N/A