NCT00936559

Brief Summary

Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2010

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

1.4 years

First QC Date

July 2, 2009

Last Update Submit

April 12, 2012

Conditions

Rotator Cuff Tear

Keywords

rotator cuff tear repairopen surgical techniquesafety

Outcome Measures

Primary Outcomes (1)

  • Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests

    1 year

Secondary Outcomes (1)

  • Investigator Questionnaire

    1 year

Study Arms (3)

1

EXPERIMENTAL

Arm A

Biological: BMP-655/ACS or Standard of Care

2

EXPERIMENTAL

Arm B

Biological: BMP-655/ACS or Standard of Care

3

EXPERIMENTAL

Arm C

Biological: BMP-655/ACS or Standard of Care

Interventions

BMP-655/ACS or Standard of CareBIOLOGICAL

Decision was made by Legal to withhold this information

1

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects and surgically sterile or postmenopausal female subjects between the ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI within 3 months before surgery.

You may not qualify if:

  • Subjects who have had previous surgical intervention to the shoulder joint under study or additional injury requiring surgical repair or a history of shoulder dislocation in the affected shoulder or physical examination findings of instability in either shoulder
  • Subjects who are unable to complete functional evaluations because of any other concurrent injuries or impairment in either the arm
  • Subjects identified with specific fatty infiltration of their RC muscles on MRI taken within 3 months prior to surgical repair
  • Subjects with moderate or severe degenerative arthritis of the shoulder under study or any bone abnormalities as confirmed on a radiograph
  • Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune disorders, treated with more than 3 corticosteroid injections in the shoulder under study within 1 year of planned surgery, any recent corticosteroid injection in the shoulder or currently receiving oral corticosteroids
  • Subjects who are either unwilling or unable to undergo examination with closed MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

Hamburg, 20246, Germany

Location

Pfizer Investigational Site

Amsterdam, Netherlands

Location

Pfizer Investigational Site

Hoofddorp, 2134 TM, Netherlands

Location

Related Publications (1)

  • Ide J, Mochizuki Y, van Noort A, Ochi H, Sridharan S, Itoi E, Greiner S. Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair-A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Part 2-A Pilot Study of Functional Recovery and Structural Outcomes. Orthop J Sports Med. 2017 Sep 12;5(9):2325967117726740. doi: 10.1177/2325967117726740. eCollection 2017 Sep.

    PMID: 28932752DERIVED

Related Links

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 10, 2009

Study Start

September 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations

NL(2)DE(2)