Microplasty Tibial Tray Data Collection

NCT00754637 | Withdrawn

• 1 other identifier: 335
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Microplasty Tibial Tray.

Conditions

Joint Disease

Keywords

Joint; Osteoarthritis; Avascular Necrosis

Outcome Measures

Primary Outcomes (1)

• Knee Society Score

  5 years

Secondary Outcomes (1)

• Radiographic Data

  10 Years

Study Arms (1)

510(k) Inclusion Criteria

Any person meeting the inclusion criteria for the device may be included in this study. These patients tend to be those seeking relief from painful or debilitating knee joint disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in need of relief frm painful or disabling Joint Disease, and meeting the 510(k) inclusion criteria on the cleared device.

You may qualify if:

• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• Correction of varus, valgus, or posttraumatic deformity.
• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
• Patient selection factors to be considered include:
• Need to obtain pain relief and improve function
• Ability and willingness of the patient to follow instructions, including control of weight and activity level
• A good nutritional state of the patient, and
• The patient must have reached full skeletal maturity
• Non-coated (Interlock®) devices are indicated for cemented application only.

You may not qualify if:

• Absolute contraindications include: infection, sepsis, and osteomyelitis.
• Relative contraindications include:
• Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
• Osteoporosis,
• Metabolic disorders which may impair bone formation,
• Osteomalacia,
• Distant foci of infections which may spread to the implant site,
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
• Vascular insufficiency, muscular atrophy, neuromuscular disease,
• Incomplete or deficient soft tissue surrounding the knee.
• Biomet Microplasty™ Tibial Trays are contraindicated for use with constrained bearings.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

The DeClaire Knee & Orthopaedic Institute

Rochester Hills, Michigan, 48307, United States

Location

Related Publications (3)

• Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.

  PMID: 2805470 BACKGROUND

• Amstutz HC, Thomas BJ, Jinnah R, Kim W, Grogan T, Yale C. Treatment of primary osteoarthritis of the hip. A comparison of total joint and surface replacement arthroplasty. J Bone Joint Surg Am. 1984 Feb;66(2):228-41.

  PMID: 6693450 BACKGROUND

• Brooks, et al. (Eds.). (2003) The Measurement and Valuation of Health Status Using EQ-5D: A European Perspective. Netherlands: Kluwer Academic Publishers.

  BACKGROUND

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ken Beres, MD

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: December 1, 2009
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

US (1)