NCT00984594

Brief Summary

The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

June 4, 2014

Completed
Last Updated

June 4, 2014

Status Verified

May 1, 2014

Enrollment Period

3.1 years

First QC Date

September 24, 2009

Results QC Date

July 10, 2013

Last Update Submit

May 22, 2014

Conditions

Knee Injury

Keywords

allograftknee injurycartilage injury

Outcome Measures

Primary Outcomes (1)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS

    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.

    24 months

Secondary Outcomes (4)

  • Current Health Assessment (CHA)

    24 months

  • IKDC Assessment

    24 months

  • Magnetic Resonance Imaging (MRI) Results

    24 months

  • Lysholm Score at 24 Months

    24 months

Study Arms (2)

Primary injury site

OTHER

CR-Plug will be placed in the site of the primary injury

Other: Primary injury site

Backfill site

OTHER

Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site

Other: Backfill site

Interventions

Primary injury siteOTHER

Autograft will be placed in the primary defect site.

Primary injury site
Backfill siteOTHER

Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.

Backfill site

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 55 years
  • skeletally mature
  • Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
  • Functional meniscal tissue (defined as 5 mmor greater)
  • A score of = or greater than 4 on the VAS questionnaire

You may not qualify if:

  • Associated tibial or patellar articular cartilage defect greater than 2 ICRS
  • Osteoarthritis of either knee
  • Mechanical axis malalignment of greater than 5 degrees
  • Patellofemoral incongruity on Merchant view
  • One or more multiple defects greater than 2.5 cm
  • Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm
  • Ligament treatments in the affected knee within one year prior to current study
  • Previous surgical meniscus treatment in the affected knee in the last 6 months
  • Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
  • use of any investigational therapy within 30 days prior to the first visit
  • Corticosteroid or viscosupplementation within the past 3 months
  • A score of 3 or less on the VAS questionnaire
  • Active gout or pseudogout or systemic inflammatory condition
  • Microfracture less than one year prior to current study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ellis and Badenhausen Orthopaedics, PSC

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Limitations and Caveats

Enrollment was closed early due to slow enrollment \& a potential change in the regulatory pathway for the allograft used in cartilage repair.

Results Point of Contact

Title
Director, Clinical Projects
Organization
RTI Biologics
rwaite@rtix.com
386-418-8888

Study Officials

  • Akbar Nawab, MD

    Ellis and Badenhausen Orthopaedics, PSC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 25, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

June 4, 2014

Results First Posted

June 4, 2014

Record last verified: 2014-05

Locations

US(1)