A Study to Evaluate the DePuy Minimally Invasive Unicompartmental Knee

NCT00734084 | Terminated Phase 4

• 1 other identifier: CT 01/34
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis

Keywords

Arthroplasty; Knee; UKA; Partial; Preservation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Preservation Unicompartmental Knee

OTHER

Minimally invasive orthopaedic implant for single compartment knee arthritis

Device: Preservation Unicompartmental Knee

Interventions

Preservation Unicompartmental Knee DEVICE

Minimally invasive orthopaedic implant for single compartment knee arthritis

Preservation Unicompartmental Knee

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

Sportsmed SA, 32 Payneham, Stepney

Adelaide, South Australia, 5069, Australia

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kim Dwyer, Ph.D

  DePuy Synthes Joint Reconstruction

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: June 1, 2001
• Primary Completion: December 1, 2004
• Study Completion: April 1, 2008
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

AU (1)