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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
Enrollment 4
Recruitment Details

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 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
Arm/Group Title Backfill Primary
Hide Arm/Group Description Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site. CR Plug will be placed in the site of the primary injury.
Period Title: Overall Study
Started 2 2 [1]
Completed 1 1
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             0             1
[1]
One patient withdrew consent and left the study before treatment.
Arm/Group Title Backfill Primary Total
Hide Arm/Group Description Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site CR Plug will be placed in the site of the primary injury Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
There are only 3 patients in the baseline analysis due to one patient withdrawing from the study before data collection.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
1
 100.0%
1
  33.3%
Between 18 and 65 years
2
 100.0%
0
   0.0%
2
  66.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 3 participants
28.5  (12.02) 17  (0) 24.7  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
0
   0.0%
1
 100.0%
1
  33.3%
Male
2
 100.0%
0
   0.0%
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Knee Injury and Osteoarthritis Outcome Score (KOOS
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 2 patients enrolled in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
Arm/Group Title Backfill Primary
Hide Arm/Group Description:
Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
CR Plug will be placed in the site of the primary injury
Overall Number of Participants Analyzed 1 1
Mean (Full Range)
Unit of Measure: units on a scale
82.74
(82.74 to 82.74)
100
(100 to 100)
2.Secondary Outcome
Title Current Health Assessment (CHA)
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
Arm/Group Title Backfill Primary
Hide Arm/Group Description:
Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
CR Plug will be placed in the site of the primary injury.
Overall Number of Participants Analyzed 1 1
Mean (Full Range)
Unit of Measure: units on a scale
80.6
(80.6 to 80.6)
100
(100 to 100)
3.Secondary Outcome
Title IKDC Assessment
Hide Description The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
Arm/Group Title Backfill Primary
Hide Arm/Group Description:
Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
CR Plug will be placed in the site of the primary injury.
Overall Number of Participants Analyzed 1 1
Mean (Full Range)
Unit of Measure: units on a scale
74.7
(74.7 to 74.7)
98.6
(98.6 to 98.6)
4.Secondary Outcome
Title Magnetic Resonance Imaging (MRI) Results
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
Arm/Group Title Backfill Primary
Hide Arm/Group Description:
Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
CR Plug will be placed in the site of the primary injury.
Overall Number of Participants Analyzed 1 1
Mean (Full Range)
Unit of Measure: units on a scale
97.1
(97.1 to 97.1)
100
(100 to 100)
5.Secondary Outcome
Title Lysholm Score at 24 Months
Hide Description The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
Arm/Group Title Backfill Primary
Hide Arm/Group Description:
Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
CR Plug will be placed in the site of the primary injury.
Overall Number of Participants Analyzed 1 1
Mean (Full Range)
Unit of Measure: units on a scale
81
(81 to 81)
100
(100 to 100)
Time Frame Patients were followed through the termination of the study, i.e. 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Backfill Primary
Hide Arm/Group Description CR-Plug will be placed in harvest site. Autograft will be placed in primary defect site.
All-Cause Mortality
Backfill Primary
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Backfill Primary
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Backfill Primary
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      1/1 (100.00%)    
Musculoskeletal and connective tissue disorders     
Increased pain in right knee *  1/2 (50.00%)  1 0/1 (0.00%)  0
Increased swelling in right knee *  1/2 (50.00%)  1 0/1 (0.00%)  0
Motor Vehicle Accident *  0/2 (0.00%)  0 1/1 (100.00%)  1
Open Reduction Internal Fixation of talus *  0/2 (0.00%)  0 1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
Enrollment was closed early due to slow enrollment & a potential change in the regulatory pathway for the allograft used in cartilage repair.
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
Name/Title: Director, Clinical Projects
Organization: RTI Biologics
Phone: 386-418-8888 ext 4172
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