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Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.

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ClinicalTrials.gov Identifier: NCT00793104
Recruitment Status : Terminated (Slow enrolment & potential regulatory changes for allograft in cartilage repair)
First Posted : November 19, 2008
Results First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Knee Injury
Intervention Procedure: Placement of allograft CR Plug in primary injury site
Enrollment 10
Recruitment Details All participants were recruited from the patient population at two investigative sites between 17 November 2008 and 11 June 2010.
Pre-assignment Details There was no group assignment
Arm/Group Title CR Plug
Hide Arm/Group Description Placement of allograft CR Plug in primary injury site
Period Title: Overall Study
Started 10
Completed 9
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title CR Plug
Hide Arm/Group Description Placement of allograft CR Plug in primary injury site
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
36.9  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months
Hide Description The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR Plug
Hide Arm/Group Description:
Placement of allograft CR Plug in primary injury site
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
86.04  (17.44)
2.Secondary Outcome
Title Current Health Assessment
Hide Description Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame 24 months, MRI only at 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR Plug
Hide Arm/Group Description:
Placement of allograft CR Plug in primary injury site
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
81.1  (22.0)
3.Secondary Outcome
Title Lysholm With Tegner Score
Hide Description The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR Plug
Hide Arm/Group Description:
Placement of allograft CR Plug in primary injury site
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.6  (22.0)
4.Secondary Outcome
Title International Knee Documentation Committee (IKDC) at 24 Months.
Hide Description The International Knee Documentation Committee scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR Plug
Hide Arm/Group Description:
Placement of allograft CR Plug in primary injury site
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
79.4  (21.8)
5.Secondary Outcome
Title MRI Evaluation Score
Hide Description MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CR Plug
Hide Arm/Group Description:
Placement of allograft CR Plug in primary injury site
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
95.5  (7.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CR Plug
Hide Arm/Group Description Placement of allograft CR Plug in primary injury site
All-Cause Mortality
CR Plug
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
CR Plug
Affected / at Risk (%) # Events
Total   2/10 (20.00%)    
Musculoskeletal and connective tissue disorders   
Graft Failure *  2/10 (20.00%)  2
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CR Plug
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Gastrointestinal disorders   
NAUSEA *  4/10 (40.00%)  4
General disorders   
whole body itching *  3/10 (30.00%)  3
tingling sensation in foot *  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Mild knee effusion *  10/10 (100.00%)  16
Moderate knee effusion *  4/10 (40.00%)  4
reduced rom, KNEE *  9/10 (90.00%)  9
knee catching *  1/10 (10.00%)  1
meniscus tear *  1/10 (10.00%)  1
plug protrusion *  1/10 (10.00%)  1
knee pain, mild *  1/10 (10.00%)  1
knee pain, moderate *  1/10 (10.00%)  1
knee pain after activity *  1/10 (10.00%)  1
increased knee pain, moderate *  1/10 (10.00%)  2
*
Indicates events were collected by non-systematic assessment

Enrollment was closed early due for 2 factors:

1) Slow enrollment and 2) A potential change in the regulatory pathway for allografts used in cartilage repair

1 patient was lost to follow up, with no data collected at the 24-month visit.

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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robin Waite , Clinical Projects Director
Organization: RI Biologics
Phone: 386-418-8888
EMail: rwaite@rtix.com
Layout table for additonal information
Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT00793104    
Other Study ID Numbers: CRP2008
WIRB # 20081109 ( Other Identifier: Western IRB )
St Francis IRB Project # 571 ( Other Identifier: St. Francis IRB )
First Submitted: November 17, 2008
First Posted: November 19, 2008
Results First Submitted: July 12, 2013
Results First Posted: December 25, 2013
Last Update Posted: December 25, 2013