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Trial Outcomes & Findings for Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee. (NCT NCT00793104)

NCT ID: NCT00793104

Last Updated: 2013-12-25

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

10 participants

Primary outcome timeframe

24 months

Results posted on

2013-12-25

Participant Flow

All participants were recruited from the patient population at two investigative sites between 17 November 2008 and 11 June 2010.

There was no group assignment

Participant milestones

Participant milestones
Measure
CR Plug
Placement of allograft CR Plug in primary injury site
Overall Study
STARTED
10
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
CR Plug
Placement of allograft CR Plug in primary injury site
Overall Study
Lost to Follow-up
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CR Plug
n=10 Participants
Placement of allograft CR Plug in primary injury site
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Age Continuous
36.9 years
STANDARD_DEVIATION 8.2 • n=93 Participants
Sex: Female, Male
Female
4 Participants
n=93 Participants
Sex: Female, Male
Male
6 Participants
n=93 Participants
Region of Enrollment
United States
10 participants
n=93 Participants

PRIMARY outcome

Timeframe: 24 months

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
CR Plug
n=9 Participants
Placement of allograft CR Plug in primary injury site
The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months
86.04 units on a scale
Standard Deviation 17.44

SECONDARY outcome

Timeframe: 24 months, MRI only at 12 and 24 months

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
CR Plug
n=9 Participants
Placement of allograft CR Plug in primary injury site
Current Health Assessment
81.1 units on a scale
Standard Deviation 22.0

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure
CR Plug
n=9 Participants
Placement of allograft CR Plug in primary injury site
Lysholm With Tegner Score
79.6 units on a scale
Standard Deviation 22.0

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure
CR Plug
n=9 Participants
Placement of allograft CR Plug in primary injury site
International Knee Documentation Committee (IKDC) at 24 Months.
79.4 units on a scale
Standard Deviation 21.8

SECONDARY outcome

Timeframe: 24 months

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
CR Plug
n=9 Participants
Placement of allograft CR Plug in primary injury site
MRI Evaluation Score
95.5 units on a scale
Standard Deviation 7.8

Adverse Events

CR Plug

Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
CR Plug
n=10 participants at risk
Placement of allograft CR Plug in primary injury site
Musculoskeletal and connective tissue disorders
Graft Failure
20.0%
2/10 • Number of events 2

Other adverse events

Other adverse events
Measure
CR Plug
n=10 participants at risk
Placement of allograft CR Plug in primary injury site
Musculoskeletal and connective tissue disorders
Mild knee effusion
100.0%
10/10 • Number of events 16
Musculoskeletal and connective tissue disorders
Moderate knee effusion
40.0%
4/10 • Number of events 4
Musculoskeletal and connective tissue disorders
reduced rom, KNEE
90.0%
9/10 • Number of events 9
Gastrointestinal disorders
NAUSEA
40.0%
4/10 • Number of events 4
General disorders
whole body itching
30.0%
3/10 • Number of events 3
General disorders
tingling sensation in foot
10.0%
1/10 • Number of events 1
Musculoskeletal and connective tissue disorders
knee catching
10.0%
1/10 • Number of events 1
Musculoskeletal and connective tissue disorders
meniscus tear
10.0%
1/10 • Number of events 1
Musculoskeletal and connective tissue disorders
plug protrusion
10.0%
1/10 • Number of events 1
Musculoskeletal and connective tissue disorders
knee pain, mild
10.0%
1/10 • Number of events 1
Musculoskeletal and connective tissue disorders
knee pain, moderate
10.0%
1/10 • Number of events 1
Musculoskeletal and connective tissue disorders
knee pain after activity
10.0%
1/10 • Number of events 1
Musculoskeletal and connective tissue disorders
increased knee pain, moderate
10.0%
1/10 • Number of events 2

Additional Information

Robin Waite , Clinical Projects Director

RI Biologics

Phone: 386-418-8888

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60