DeNovo NT Natural Tissue Graft Stratified Knee Study

Knee Injuries Clinical Trial

Official title:

A Stratified, Post-Market Study of DeNovo NT for the Treatment of Femoral and Patellar Articular Cartilage Lesions of the Knee

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01670617
• Other study ID #: CSU2011-03B
• Status: Active, not recruiting
• Phase: N/A
• First received: August 8, 2012
• Last updated: January 25, 2017
• Start date: March 2012
• Est. completion date: December 2021

Study information

• Verified date: December 2016
• Source: Zimmer Orthobiologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long-term relief of pain and return to function for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed product and has been used in more than 7,500 patients over the last 7 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

INCLUSION CRITERIA:

1. Voluntary signature of the IRB approved Informed Consent,

2. Male or female subjects between the ages of 18 to 55 years,

3. If female: Actively practicing a contraception method and willing to continue for a minimum of 1 year postoperatively, practicing abstinence and willing to continue for a minimum of 1 year postoperatively, or sterile

4. One or two contained lesion(s) of the femur or patella = ICRS Grade 3 or OCD lesions with healed bone base with no loss of bone greater than 6mm

5. Has peripheral cartilage debridement to healthy cartilage that results in at least one lesion with an area of = 2 cm2 and = 7.5 cm2,

6. Lesion(s) to be treated must be contained/shouldered > 70% of the periphery,

7. Ligaments in the affected knee are stable,

8. Ipsilateral knee compartment has intact menisci

9. The contralateral knee is asymptomatic, stable, and fully functional,

10. Is refractory to conservative non-surgical management or minimal surgical intervention and = 3 months from the start of either treatment,

11. Must record a response, at the preoperative study visit, of moderate to extreme pain for any one of the KOOS Pain Scale questions, P2 through P9.

12. Must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol

EXCLUSION CRITERIA:

1. Clinical 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,

• Bipolar articular cartilage involvement (or kissing lesions)

• Has more than two clinically relevant chondral lesion(s) on the index knee,

• Osteochondritis dissecans of the knee with significant bone loss

• Associated damage to the underlying subchondral bone requiring bone graft,

• Has well-defined subchondral cyst(s),

• Has current or impending subchondral avascular necrosis,

2. History of secondary arthropathies (i.e., sickle cell disease, hemochromatosis, or autoimmune disease),

3. Uncontrolled diabetes,

4. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease,

5. Has HIV or other immunodeficient state

6. Is at substantial risk for the need of organ transplantation

7. Is pregnant or breast-feeding,

8. Body Mass Index >35 (BMI=kg/m2),

9. Is participating concurrently in another clinical trial

10. Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulants, or taking corticosteroids,

11. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee,

12. Active joint infection or history of chronic joint infection at the surgical site,

13. Prior total meniscectomy of either knee,

14. Has severe patellofemoral malalignment/maltracking or patellar instability

15. Radiographically has >5 degrees of malalignment

16. Has received, within the past 3 months HA or cortisone injections in knee,

17. Has undergone prior tendon repair, meniscus repair, ligament repair or distal realignment/osteotomy surgery in the index knee, < 6 months prior to surgery,

18. Failed marrow stimulation or ACI treatment performed < 12-mo before baseline,

19. Index knee has been surgically treated for cartilage repair with OATs, mosaicplasty or osteochondral allograft,

20. Involves concomitant procedures in the affected knee with the exception of incidental loose body removal, debridement, synovectomy, retinacular release, and/or partial meniscectomy

21. Has contraindications for Magnetic Resonance Imaging (MRI),

22. Has an allergy to Polymyxin B sulfate or Bacitracin antibiotics,

23. Is receiving workman's compensation or currently involved in litigation relating to the index knee

Related Conditions & MeSH terms

• Cartilage Diseases
• Defect of Articular Cartilage
• Knee Injuries

Intervention

Other:
• Particulated Juvenile Articular Cartilage
Treatment of articular cartilage defects up to 7.5 cm2

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	Women's College Hospital	Toronoto
United States	New Mexico Orthopaedic Consultants	Albuquerque	New Mexico
United States	Emory Spine & Sports Medicine Center	Atlanta	Georgia
United States	Colorado Orthopedic Consultants	Aurora	Colorado
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	TRIA Orthopaedic Center	Bloomington	Minnesota
United States	University of Virginia	Charlottesville	Virginia
United States	Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics	Edina	Minnesota
United States	Andrews Institute for Orthopaedics & Sports Medicine	Gulf Breeze	Florida
United States	A.T. Still University of Health Sciences	Kirksville	Missouri
United States	Kerlan Jobe Orthopaedics	Los Angeles	California
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	Oregon Health & Science University	Portland	Oregon
United States	San Antonio Military Medical Center	San Antonio	Texas
United States	Naval Medical Center San Deigo	San Deigo	California
United States	University Orthopaedic Associates	Somerset	New Jersey
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Orthobiologics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Farr J, Cole BJ, Sherman S, Karas V. Particulated articular cartilage: CAIS and DeNovo NT. J Knee Surg. 2012 Mar;25(1):23-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in KOOS scores	Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores	Between baseline and 24 months post surgery
Secondary	X-ray Evaluation	X-ray evaluation of joint narrowing, and osteophyte and cyst formation	Preop, 12 months and 24 months post surgery
Secondary	Incidence and time to reoperation/revision		5 years
Secondary	Mean IKDC Knee Examination grades		Annually to 5 years post surgery
Secondary	MRI Evaluation	Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score	Preop, 12 Months and 24 Months post surgery
Secondary	Incidence of adverse events		Annually to 5 years post surgery