Post Market Study of DeNovo NT, Natural Tissue Graft

NCT00791245 | Completed

• 1 other identifier: ISTO - DeNovo NT 03-07-02
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this post market study is to evaluate surgical implantation technique and the quality of repair of the cartilage defect with particulated juvenile cartilage in the human knee joint.

Conditions

Cartilage Repair

Keywords

ISTO Technologies, Inc; cartilage repair; arthroscopy; 361 HCT/P; human tissue; biologic; knee

Outcome Measures

Primary Outcomes (1)

• KOOS

  Preoperatively, postoperatively at 10 Days, 3, 6, 12, 18 & 24 Months

Secondary Outcomes (1)

• IKDC Subjective Knee Evaluation

  Preopertively, postoperatively at 10 Days, 3, 6, 12, 18, & 24 Months

Study Arms (1)

1

DeNovo NT

Biological: Particulated Juvenile Cartilage Allograft

Interventions

Particulated Juvenile Cartilage Allograft BIOLOGICAL

Particulated Juvenile Cartilage Allograft

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Clinical population

You may qualify if:

• Voluntary signature of the IRB approved Informed Consent
• Male or female subjects between the ages of 18 to 55 years
• If female:
• Actively practicing a contraception method, or
• Practicing abstinence, or
• Surgically sterilized, or
• Postmenopausal
• Pretreatment arthroscopic confirmation indicating one or two contained lesion(s) are equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle or trochlear groove and OCD lesions (Grade 4a) with healed bone base, which is non sclerotic and no loss of bone greater than 6mm measured from the surrounding subchondral plate,
• Has peripheral cartilage debridement to healthy cartilage that results in a lesion(s) with an area of greater than or equal to 1 cm squared and less than or equal to 5 cm squared,
• PCL, LCL and MCL in the affected knee are stable and the ACL is stable or can be stabilized as a concomitant procedure,
• Ipsilateral knee compartment has intact menisci (or requires partial meniscectomy resulting in stable menisci),
• The contralateral knee is asymptomatic, stable and fully functional,
• Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits through 24 months.

You may not qualify if:

• Clinical and/or radiographic disease diagnosis of the indexed affected joint that includes:
• Osteoarthritis or avascular necrosis,
• Rheumatoid arthritis, or history of septic or reactive arthritis,
• Gout or a history of gout or pseudogout in the affected knee,
• Osteochondritis dissecans of the knee with significant bone loss (greater than 6mm deep from the subchondral plate),
• Associated damage to the underlying subchondral bone requiring an osteochondral graft,
• History of secondary arthropathies (i.e. sickle cell disease, hemochromatosis, or autoimmune disease),
• Uncontrolled diabetes,
• Displays a high surgical risk due to unstable cardiac and/or pulmonary disease,
• Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint,
• Is at substantial risk for the need of organ transplantation, such as renal insufficiency,
• Is pregnant or breast-feeding,
• Body Mass Index \>35 (BMI=kg/m2),
• Has bipolar articular cartilage involvement or kissing lesions of the ipsilateral compartment, described as tibial or patellar lesions in the same compartment with greater than ICRS Grade 2 chondrosis,
• Is participating concurrently in another clinical trial, or has participated ina clinical trial within 30 days of surgery,

Sponsors & Collaborators

• Zimmer Orthobiologics, Inc.: lead

Study Sites (3)

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

Location

OrthoIndy

Indianapolis, Indiana, 46237, United States

Location

New Mexico Orthopaedic Association, PC

Albuquerque, New Mexico, 87106, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: January 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

US (3)