A Study to Evaluate the DePuy Minimally Invasive Unicompartmental Knee

Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00734084
• Other study ID #: CT 01/34
• Status: Terminated
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: June 5, 2015
• Start date: June 2001
• Est. completion date: April 2008

Study information

• Verified date: June 2015
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 247
• Est. completion date: April 2008
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Preservation Unicompartmental Knee
Minimally invasive orthopaedic implant for single compartment knee arthritis

Locations

Country	Name	City	State
Australia	Sportsmed SA, 32 Payneham, Stepney	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes