A Study to Evaluate the DePuy Minimally Invasive Unicompartmental Knee - Full Text View

Sponsored by:	DePuy International
Information provided by:	DePuy International
ClinicalTrials.gov Identifier:	NCT00734084

Purpose

The primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting.

The secondary objective of this investigation is to evaluate the long-term survivorship of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.

Condition	Intervention	Phase
Osteoarthritis	Device: Preservation Unicompartmental Knee	Phase IV

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Non-Comparative Multi-Centre Study to Evaluate the Safety and Performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation.

Further study details as provided by DePuy International:

Primary Outcome Measures:

To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiographic assessment, Oxford Knee Score and survivorship analysis. [ Time Frame: 6 months, 1, 3, 5, 10 and 15 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2002
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Minimally invasive orthopaedic implant for single compartment knee arthritis

Detailed Description:

Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using radiographic and intra-operative assessment.

Secondary endpoints - to demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiological assessment, Oxford Knee Score and survivorship analysis.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects, who are 40 to 75 years of age inclusive.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom written consent has been obtained.
Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Subjects who exhibit loss of articular cartilage which is predominantly confined to a single compartment. The remaining compartments must be intact and able to bear normal loads.
Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
Subjects with a known history of poor compliance to medical treatment.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
Subjects who have participated in a clinical study with an investigational product in the last month.
Subjects who are currently involved in any injury litigation claims.
Revision of an existing unicompartmental implant.
Subjects who have gross ligament laxity / instability.
Subjects who have an inflammatory joint disease
Subjects in whom there is evidence of previous joint sepsis
Subjects who have a pre-operative flexion contracture of 15° or greater
Subjects who have a pre-operative flexion of less than 90°
Subjects who have a pre-operative limb deformity of greater than 15° varus or valgus
Subjects who have morbid obesity i.e. BMI > 40%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734084

Locations

Australia
Sportsmed SA
Adelaide, Australia

Sponsors and Collaborators

DePuy International

Investigators

Principal Investigator:

Greg Keene, FRCS

Sportsmed, Stepney, Adelaide

More Information

Responsible Party:	DePuy International (see above) ( Mick Borroff )
Study ID Numbers:	CT 01/34
Study First Received:	August 11, 2008
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00734084
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:

Arthroplasty
Knee
UKA
Partial
Preservation

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009