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Study of the HemiCAP™ Unicondylar Femoral Resurfacing Prosthesis."

This study has been completed.
Sponsor:
Collaborators:
Boston Medical Center
UHZ Sports Medicine Institute
University of Iowa
Fowler Kennedy Sport Medicine Clinic
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
Arthrosurface, Inc.
ClinicalTrials.gov Identifier:
NCT00158444
First received: September 8, 2005
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
Patients with large unstable Grade IV articular surface defects, with significant subchondral bone exposure and who will likely receive a joint replacement will receive the HemiCAP™ Femoral Resurfacing Prosthesis. The Subject Device intends to offer a surgical alternative to these patients who might otherwise endure years of pain and loss of function while awaiting a more appropriate age for joint replacement surgery.

Condition Intervention
Osteoarthritis
Avascular Necrosis
Device: HemiCAP Resurfacing

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "A Prospective, Non-Randomized, Non-Comparative, Open Label Multi-Center, Feasibility Study to Examine the Safety and Effectiveness of the HemiCAP™ Unicondylar Femoral Resurfacing Prosthesis."

Further study details as provided by Arthrosurface, Inc.:

Primary Outcome Measures:
  • 20% or greater improvement in WOMAC score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • No secondary surgical intervention related to a device-related adverse event occurred [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stable implant (no subsidence, loosening or radiolucency) on radiographic evaluation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • SF36 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • WOMAC [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • physical examination [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: August 2005
Study Completion Date: November 2013
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HemiCAP resurfacing
insertion of a focal thermocondyl resurfacing device for inlay athroplasty
Device: HemiCAP Resurfacing
intraoperative joint surface mapping and implantation of patient specific, matching inlay resurfacing prosthetic

Detailed Description:

The objective of the proposed clinical investigation is to determine safety and effectiveness of the investigational device in the management of pain and restoration of joint function as part of an interim clinical treatment strategy.

This is a pivotal, prospective, non-randomized, non-comparative, open label clinical study, to evaluate the safety and effectiveness of the HemiCAP™ Femoral Resurfacing Prosthesis.

The study will involve up to 15 qualified investigational sites.

Patients who meet the inclusion/exclusion criteria will be consented by the coordinator for the study at the centre and receive a baseline evaluation and knee exam. Standard radiographs will be taken and the subject will fill out quality of life questionnaires. The surgical procedure will take place within 1 month of the baseline evaluation.

Follow-up evaluations will occur at 2 weeks, 6 weeks and 3 months following the surgery. At these evaluations, radiographs will be taken and the patient will fill out a post-op progress and satisfaction assessment forms. Any concomitant medications and adverse events will be documented. In addition at 6, 12 and 24 months following the surgery, the patients will fill out the quality of life questionnaires.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- We can only include Canadians in our study

  • Pre-operative Inclusion Criteria: Patients must meet all of the following criteria to be eligible to be enrolled into the study:

    • Patient age greater than or equal to 40 years.
    • Articular surface defect located on the medial or lateral femoral condyle.
    • Articular surface defect that penetrates or exposes subchondral bone.
    • Clinical symptoms meet criteria established in the Cincinnati Knee Rating System, Symptom Rating Form for Patient Grade less than or equal to 5 (on 1-10 scale) or, Pain associated with function is less than or equal to 5 (on 1-10 scale) or symptoms of weight bearing pain significantly limit the patients quality of life.
    • Patient must have failed conservative care and a) undergone recognized arthroscopic surgical interventions, such as previous marrow stimulation cartilage repairs (drilling, micro-fracture or abrasions); or not be an appropriate candidate for these surgical interventions or b) have not undergone a recognized arthroscopic intervention for the treatment of defect, including patients suffering from Avascular Necrosis (AVN).
    • Patient exhibits overall well being, has signed the informed consent form, and is willing to follow instructions and comply with activity restrictions.
    • Patient understands and is willing to comply with the follow-up requirements of the study.Intra-Operative Inclusion CriteriaPatients must meet all of the following intra-operative criteria to be included in the study:
    • Articular surface defect can be largely circumscribed by a 15mm or 20mm diameter circular sizing guide.
    • Articular surface defect is located relatively central to the femoral condyle so that resurfacing implant does not extend beyond the limit of the condyle. -

Exclusion Criteria:

  1. Patient is obese, defined as BMI > 30kg/m2, at screening.
  2. Patient is known to be infected with HIV or has acquired AIDS.
  3. Patient is known to have a history of substance abuse.
  4. Patient displays varus joint mal-alignment, in the affected limb only, of greater than 2º anatomic or 7º mechanical.
  5. Patient presents evidence of metabolic disorders, which may impair the formation or healing of bone.
  6. Patient presents evidence of infections at remote sites, which may spread to the implant site.
  7. Patient presents evidence of rheumatoid arthritis, gross joint destruction, infectious/crystal arthropathies or bone resorption visible on roentgenogram.
  8. Patient presents evidence of chronic instability or deficient soft tissues, support structures, vascular or muscular insufficiency.
  9. Patient has a known sensitivity to materials typically used in orthopedic implants.
  10. Patient has irresolvable joint pain or loss of function with an undeterminable cause.
  11. Patient who suspects or is confirmed to be pregnant. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158444

Locations
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
Arthrosurface, Inc.
Boston Medical Center
UHZ Sports Medicine Institute
University of Iowa
Fowler Kennedy Sport Medicine Clinic
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Robert B Litchfield, MD, FRCSC Fowler Kennedy Sport Medicine Clinic
  More Information

Publications:
Buckwalter JA, Mankin HJ. Articular Cartilage, Part II: Degeneration and Osteoarthrosis, repair, regeneration, and transplantation. JBJS 79A:612-632, 1997.
Cole MD, Brian J, D'Amato M. Autologous Chondrocyte Implantation. Operative Techniques in Orthopaedics 115-131, April 2001.
Rosenberg TD, Weiss JA, Moulis PM, Deffner KT, Cooley VJ. Finite Element Simulation of Stresses in Chondral Defects. Int Cart Repair Soc Newsletter 2:14, 1999.
Bobic MD, Vladimir. The Utilisation of Osteochondral Autografts in the Treatment of Articular Cartilage Lesions. International Society of Arthroscopy, Knee Surgery and Orthopaedic Sport Medicine 2000, www.isakos.com.

Responsible Party: Arthrosurface, Inc.
ClinicalTrials.gov Identifier: NCT00158444     History of Changes
Other Study ID Numbers: FKSMC-Industry-1 
Study First Received: September 8, 2005
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Arthrosurface, Inc.:
arthroplasty
Resurfacing
implant

Additional relevant MeSH terms:
Osteoarthritis
Necrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016