Trial Outcomes & Findings for Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects (NCT NCT00984594)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4 participants

Primary outcome timeframe

24 months

Results posted on

2014-06-04

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	2	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Backfill n=2 Participants Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site	Primary n=1 Participants CR Plug will be placed in the site of the primary injury	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.5 years STANDARD_DEVIATION 12.02 • n=5 Participants	17 years STANDARD_DEVIATION 0 • n=7 Participants	24.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Of the 2 patients enrolled in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.

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.

Outcome measures

Outcome measures
Measure	Backfill n=1 Participants Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site	Primary n=1 Participants CR Plug will be placed in the site of the primary injury
Knee Injury and Osteoarthritis Outcome Score (KOOS	82.74 units on a scale Interval 82.74 to 82.74	100 units on a scale Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 24 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Backfill n=1 Participants Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site	Primary n=1 Participants CR Plug will be placed in the site of the primary injury
Current Health Assessment (CHA)	80.6 units on a scale Interval 80.6 to 80.6	100 units on a scale Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 24 months

Population: 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.

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,

Outcome measures

Outcome measures
Measure	Backfill n=1 Participants Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site	Primary n=1 Participants CR Plug will be placed in the site of the primary injury
IKDC Assessment	74.7 units on a scale Interval 74.7 to 74.7	98.6 units on a scale Interval 98.6 to 98.6

SECONDARY outcome

Timeframe: 24 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Backfill n=1 Participants Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site	Primary n=1 Participants CR Plug will be placed in the site of the primary injury
Magnetic Resonance Imaging (MRI) Results	97.1 units on a scale Interval 97.1 to 97.1	100 units on a scale Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 24 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Backfill n=1 Participants Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site	Primary n=1 Participants CR Plug will be placed in the site of the primary injury
Lysholm Score at 24 Months	81 units on a scale Interval 81.0 to 81.0	100 units on a scale Interval 100.0 to 100.0

Adverse Events

Backfill

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Primary

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Backfill n=2 participants at risk CR-Plug will be placed in harvest site.	Primary n=1 participants at risk Autograft will be placed in primary defect site.
Musculoskeletal and connective tissue disorders Increased pain in right knee	50.0% 1/2 • Number of events 1 • Patients were followed through the termination of the study, i.e. 24 months	0.00% 0/1 • Patients were followed through the termination of the study, i.e. 24 months
Musculoskeletal and connective tissue disorders Increased swelling in right knee	50.0% 1/2 • Number of events 1 • Patients were followed through the termination of the study, i.e. 24 months	0.00% 0/1 • Patients were followed through the termination of the study, i.e. 24 months
Musculoskeletal and connective tissue disorders Motor Vehicle Accident	0.00% 0/2 • Patients were followed through the termination of the study, i.e. 24 months	100.0% 1/1 • Number of events 1 • Patients were followed through the termination of the study, i.e. 24 months
Musculoskeletal and connective tissue disorders Open Reduction Internal Fixation of talus	0.00% 0/2 • Patients were followed through the termination of the study, i.e. 24 months	100.0% 1/1 • Number of events 1 • Patients were followed through the termination of the study, i.e. 24 months

Additional Information

Director, Clinical Projects

RTI Biologics

Phone: 386-418-8888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60