Clinical Trial: Study of the HemiCAP™ Unicondylar Femoral Resurfacing Prosthesis."

Study of the HemiCAP™ Unicondylar Femoral Resurfacing Prosthesis.”

This study is currently recruiting patients.
Verified by Fowler Kennedy Sport Medicine Clinic September 2005

Sponsors and Collaborators: Fowler Kennedy Sport Medicine Clinic
Arthrosurface, Inc.
Information provided by: Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier: NCT00158444

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
 Procedure: insertion of the HemiCAP™ Femoral Resurfacing Prosthesis

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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: 
Primary Outcomes: Effectiveness:The Self-Reported Patient Pain scores will be reported for the baseline and 24-month assessments.; Safety:; * Reoperation rate; * Patient disposition; * Radiograph data; * Operative procedures/findings; * Concomitant medications; * adverse events; * Post-operative recovery and length of hospital stay data
Secondary Outcomes: * Patient Grade, Swelling, Giving-Way, and Locking; * Activities of Daily Living, Functional Scores; * Occupational Rating Scores; Secondary Effectiveness determination improvement in the Cincinnati Knee Rating System:; * Physician Exam; flexion, extension, quadriceps strength; * SF-36; * WOMAC
Expected Total Enrollment:  20

Study start: August 2005;  Expected completion: May 2009
Last follow-up: December 2008;  Data entry closure: February 2009

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 above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Pre-operative Inclusion CriteriaPatients 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. -

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00158444

Sharon Griffin, CSS      519-661-2111  Ext. 87505    sharon.griffin@uwo.ca

Canada, Ontario
      Fowler Kennedy Sport Medicine Clinic, London,  Ontario,  N6A 3K7,  Canada; Recruiting
Robert B Litchfield, MD,FRCSC  519-661-4156    rlitchf@uwo.ca 
Sharon Griffin, CSS  519-661-2111  Ext. 87505    sharon.griffin@uwo.ca 
Robert B Litchfield, MD, FRCSC,  Principal Investigator
Kevin Willits, MD,FRCSC,  Sub-Investigator
James R Giffin, MD. FRCSC,  Sub-Investigator

Study chairs or principal investigators

Robert B Litchfield, MD, FRCSC,  Principal Investigator,  Fowler Kennedy Sport Medicine Clinic   

More Information

Study ID Numbers:  FKSMC-Industry-1
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158444
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13

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