Study of the HemiCAP™ Unicondylar Femoral Resurfacing Prosthesis."

Osteoarthritis Clinical Trial

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."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158444
• Other study ID #: FKSMC-Industry-1
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: July 20, 2016
• Start date: August 2005
• Est. completion date: November 2013

Study information

• Verified date: July 2016
• Source: Arthrosurface, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 2013
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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. -

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteoarthritis

Intervention

Device:
• HemiCAP Resurfacing
intraoperative joint surface mapping and implantation of patient specific, matching inlay resurfacing prosthetic

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sport Medicine Clinic	London	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
Arthrosurface, Inc.	Boston Medical Center, Fowler Kennedy Sport Medicine Clinic, Hospital for Special Surgery, New York, UHZ Sports Medicine Institute, University of Iowa

Country where clinical trial is conducted

Canada, 

References & Publications (31)

Blevins FT, Steadman JR, Rodrigo JJ, Silliman J. Treatment of articular cartilage defects in athletes: an analysis of functional outcome and lesion appearance. Orthopedics. 1998 Jul;21(7):761-7; discussion 767-8. — View Citation

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.

Buckwalter JA, Mankin HJ. Articular Cartilage, Part II: Degeneration and Osteoarthrosis, repair, regeneration, and transplantation. JBJS 79A:612-632, 1997.

Bugbee WD, Convery FR. Osteochondral allograft transplantation. Clin Sports Med. 1999 Jan;18(1):67-75. — View Citation

Bugbee WD. Fresh osteochondral allografts. J Knee Surg. 2002 Summer;15(3):191-5. — View Citation

Cain EL, Clancy WG. Treatment algorithm for osteochondral injuries of the knee. Clin Sports Med. 2001 Apr;20(2):321-42. Review. — View Citation

Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994 May 4;271(17):1349-57. — View Citation

Cole MD, Brian J, D'Amato M. Autologous Chondrocyte Implantation. Operative Techniques in Orthopaedics 115-131, April 2001.

Curl WW, Krome J, Gordon ES, Rushing J, Smith BP, Poehling GG. Cartilage injuries: a review of 31,516 knee arthroscopies. Arthroscopy. 1997 Aug;13(4):456-60. — View Citation

De Smet AA, Ilahi OA, Graf BK. Untreated osteochondritis dissecans of the femoral condyles: prediction of patient outcome using radiographic and MR findings. Skeletal Radiol. 1997 Aug;26(8):463-7. — View Citation

Gilbert JE. Current treatment options for the restoration of articular cartilage. Am J Knee Surg. 1998 Winter;11(1):42-6. Review. — View Citation

Gustilo T, Comadoll JL, Gustilo RB. Long-term results of 56 revision total knee replacements. Orthopedics. 1996 Feb;19(2):99-103. — View Citation

Hangody L, Feczkó P, Bartha L, Bodó G, Kish G. Mosaicplasty for the treatment of articular defects of the knee and ankle. Clin Orthop Relat Res. 2001 Oct;(391 Suppl):S328-36. Review. — View Citation

Hangody L, Kish G, Kárpáti Z, Udvarhelyi I, Szigeti I, Bély M. Mosaicplasty for the treatment of articular cartilage defects: application in clinical practice. Orthopedics. 1998 Jul;21(7):751-6. — View Citation

Hjelle K, Solheim E, Strand T, Muri R, Brittberg M. Articular cartilage defects in 1,000 knee arthroscopies. Arthroscopy. 2002 Sep;18(7):730-4. — View Citation

Hungerford MW, Mont MA, Scott R, Fiore C, Hungerford DS, Krackow KA. Surface replacement hemiarthroplasty for the treatment of osteonecrosis of the femoral head. J Bone Joint Surg Am. 1998 Nov;80(11):1656-64. — View Citation

Jackson DW, Lalor PA, Aberman HM, Simon TM. Spontaneous repair of full-thickness defects of articular cartilage in a goat model. A preliminary study. J Bone Joint Surg Am. 2001 Jan;83-A(1):53-64. — View Citation

Jürgensen I, Bachmann G, Schleicher I, Haas H. Arthroscopic versus conservative treatment of osteochondritis dissecans of the knee: value of magnetic resonance imaging in therapy planning and follow-up. Arthroscopy. 2002 Apr;18(4):378-86. — View Citation

Kish G, Módis L, Hangody L. Osteochondral mosaicplasty for the treatment of focal chondral and osteochondral lesions of the knee and talus in the athlete. Rationale, indications, techniques, and results. Clin Sports Med. 1999 Jan;18(1):45-66, vi. Review. — View Citation

Linden B. Osteochondritis dissecans of the femoral condyles: a long-term follow-up study. J Bone Joint Surg Am. 1977 Sep;59(6):769-76. — View Citation

Micheli LJ, Browne JE, Erggelet C, Fu F, Mandelbaum B, Moseley JB, Zurakowski D. Autologous chondrocyte implantation of the knee: multicenter experience and minimum 3-year follow-up. Clin J Sport Med. 2001 Oct;11(4):223-8. — View Citation

Minas T. Chondrocyte implantation in the repair of chondral lesions of the knee: economics and quality of life. Am J Orthop (Belle Mead NJ). 1998 Nov;27(11):739-44. — View Citation

Mont MA, Myers TH, Krackow KA, Hungerford DS. Total knee arthroplasty for corticosteroid associated avascular necrosis of the knee. Clin Orthop Relat Res. 1997 May;(338):124-30. — View Citation

Noyes FR, Bassett RW, Grood ES, Butler DL. Arthroscopy in acute traumatic hemarthrosis of the knee. Incidence of anterior cruciate tears and other injuries. J Bone Joint Surg Am. 1980 Jul;62(5):687-95, 757. — View Citation

O'Driscoll SW. The healing and regeneration of articular cartilage. J Bone Joint Surg Am. 1998 Dec;80(12):1795-812. Review. — View Citation

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.

Salai M, Ganel A, Horoszowski H. Fresh osteochondral allografts at the knee joint: good functional results in a follow-up study of more than 15 years. Arch Orthop Trauma Surg. 1997;116(6-7):423-5. — View Citation

Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002 Nov;(404):7-13. — View Citation

Siguier M, Judet T, Siguier T, Charnley G, Brumpt B, Yugue I. Preliminary results of partial surface replacement of the femoral head in osteonecrosis. J Arthroplasty. 1999 Jan;14(1):45-51. — View Citation

Sledge SL. Microfracture techniques in the treatment of osteochondral injuries. Clin Sports Med. 2001 Apr;20(2):365-77. Review. — View Citation

Soucacos PN, Xenakis TH, Beris AE, Soucacos PK, Georgoulis A. Idiopathic osteonecrosis of the medial femoral condyle. Classification and treatment. Clin Orthop Relat Res. 1997 Aug;(341):82-9. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20% or greater improvement in WOMAC score		24 months	No
Primary	No secondary surgical intervention related to a device-related adverse event occurred		2 years	Yes
Secondary	Stable implant (no subsidence, loosening or radiolucency) on radiographic evaluation		24 months	Yes
Secondary	SF36		24 months	No
Secondary	WOMAC		24 months	No
Secondary	physical examination		24 months	Yes