Trial Outcomes & Findings for Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee. (NCT NCT00821873)

Last Updated: 2013-11-28

Results Overview

The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively. The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

9 participants

Primary outcome timeframe

24 months

Results posted on

2013-11-28

Participant Flow

All participants were recruited from the patient population at the four investigative sites

This was a single arm study, thus there is no assignment

Participant milestones

Participant milestones
Measure	CR Plug BackFill Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
Overall Study STARTED	9
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	CR Plug BackFill Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
Overall Study Lost to Follow-up	4

Baseline Characteristics

Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CR Plug BackFill n=9 Participants Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	33.1 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Outcome measures

Outcome measures
Measure	CR Plug BackFill n=5 Participants Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
MRI to Evaluate Success of Outcome.	88.6 units on a scale Standard Deviation 5.7

Adverse Events

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adverse Events n=9 participants at risk Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
Musculoskeletal and connective tissue disorders Collapse of Graft	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders PAIN IN RIGHT KNEE	11.1% 1/9 • Number of events 1
Gastrointestinal disorders VOMITING NAUSEA	22.2% 2/9 • Number of events 2
General disorders MEDICATION REACTION	11.1% 1/9 • Number of events 1
Gastrointestinal disorders DIARRHEA	22.2% 2/9 • Number of events 2
Musculoskeletal and connective tissue disorders FELL ON KNEE	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders PAIN RIGHT KNEE FROM FALL	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders PAIN IN RIGHT KNEE FORM COLD	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders SWELLING IN RIGHT KNEE	11.1% 1/9 • Number of events 1
General disorders ABDOMINAL PAIN	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders TRANSIENT KNEE EFFUSION	11.1% 1/9 • Number of events 1
General disorders CHEST PAIN	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders INFECTION OF LEFT KNEE	11.1% 1/9 • Number of events 1
General disorders RIGHT LEG SWELLING	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders INCREASED KNEE EFFUSION DUE TO FALL	11.1% 1/9 • Number of events 1
Psychiatric disorders DEPRESSION	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders QUADRICEPS ATROPHY - IPSILATERAL LEG	11.1% 1/9 • Number of events 1
General disorders KIDNEY STONES	11.1% 1/9 • Number of events 1

Additional Information

Robin Waite, 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: LTE60