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Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects

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ClinicalTrials.gov Identifier: NCT00984594
Recruitment Status : Terminated (Slow enrolment & potential regulatory changes for allograft in cartilage repair)
First Posted : September 25, 2009
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Knee Injury
Interventions: Other: Primary injury site
Other: Backfill site

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

All participants were recruited from the patient population at one of the investigative sites between 12 June 2009 and 5 May 2010.

One subject was enrolled at 17 years, 7 months. A protocol waiver was approved by the Institutional Review Board and parental informed consent and assent of subject was obtained.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were assigned to the treatment arm based on a randomization table. Enrolled patients excluded: Not fulfilling inclusion or exclusion criteria, withdrawal of consent. Enrolled patients were followed to completion unless lost to follow up. Of 4 enrolled, 1 withdrew consent, 1 was lost to follow up & 2 completed

Reporting Groups
  Description
Backfill Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
Primary CR Plug will be placed in the site of the primary injury.

Participant Flow:   Overall Study
    Backfill   Primary
STARTED   2   2 [1] 
COMPLETED   1   1 
NOT COMPLETED   1   1 
Lost to Follow-up                1                0 
Withdrawal by Subject                0                1 
[1] One patient withdrew consent and left the study before treatment.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
There are only 3 patients in the baseline analysis due to one patient withdrawing from the study before data collection.

Reporting Groups
  Description
Backfill Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
Primary CR Plug will be placed in the site of the primary injury
Total Total of all reporting groups

Baseline Measures
   Backfill   Primary   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   1   3 
Age 
[Units: Participants]
     
<=18 years   0   1   1 
Between 18 and 65 years   2   0   2 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.5  (12.02)   17  (0)   24.7  (10.8) 
Gender 
[Units: Participants]
     
Female   0   1   1 
Male   2   0   2 
Region of Enrollment 
[Units: Participants]
     
United States   2   1   3 


  Outcome Measures

1.  Primary:   Knee Injury and Osteoarthritis Outcome Score (KOOS   [ Time Frame: 24 months ]

2.  Secondary:   Current Health Assessment (CHA)   [ Time Frame: 24 months ]

3.  Secondary:   IKDC Assessment   [ Time Frame: 24 months ]

4.  Secondary:   Magnetic Resonance Imaging (MRI) Results   [ Time Frame: 24 months ]

5.  Secondary:   Lysholm Score at 24 Months   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Enrollment was closed early due to slow enrollment & a potential change in the regulatory pathway for the allograft used in cartilage repair.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Projects
Organization: RTI Biologics
phone: 386-418-8888 ext 4172
e-mail: rwaite@rtix.com



Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT00984594     History of Changes
Other Study ID Numbers: CR2008
First Submitted: September 24, 2009
First Posted: September 25, 2009
Results First Submitted: July 10, 2013
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014