A Study to Evaluate the DePuy Minimally Invasive Unicompartmental Knee

A Prospective, Non-Comparative Multi-centre Study to Evaluate the Safety and Performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation.

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Preservation Unicompartmental Knee

Detailed Description

Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using postoperative radiographic limb and component alignment data.

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.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5069
      • Sportsmed SA, 32 Payneham, Stepney

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Preservation Unicompartmental Knee; Minimally invasive orthopaedic implant for single compartment knee arthritis	Device: Preservation Unicompartmental Knee; Minimally invasive orthopaedic implant for single compartment knee arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment	Intraoperative	0 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	6 months, 1, 3, 5, 10 and 15 years

Collaborators and Investigators

• Sponsor: DePuy International
• Investigators: Study Chair: Kim Dwyer, Ph.D, DePuy Synthes Joint Reconstruction

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: August 11, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Estimate): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 5, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Arthroplasty; Knee; Partial; Preservation; UKA
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CT 01/34