Regenerex Tibial Tray Multi-Center Data Collection

Pain Clinical Trial

Official title:

Regenerex Tibial Tray Multi-Center Data Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859963
• Other study ID #: ORTHO.CR.ROWG2 (US 25)
• Status: Completed
• Start date: March 2009
• Est. completion date: December 2018

Study information

• Verified date: December 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

See Protocol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

The inclusion criteria will be identical to the indications stated in the FDA approved

labeling for the device (cleared in 510(k) K080361. These indications are stated below:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, or arthrodesis.

Patient selection factors to be considered include:

1. Ability and willingness of the patient to follow instructions, including control of weight and activity level

2. A good nutritional state of the patient, and

3. The patient must have reached full skeletal maturity Exclusion Criteria: The exclusion criteria will be identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K080361. These contraindications are

stated below:

• Absolute contraindications include: infection, sepsis, osteomyelitis, and failure of a previous joint replacement.
• Relative contraindications include:

1. Uncooperative patient or patient with neurologic disorders who are incapable of following directions,

2. Osteoporosis,

3. Metabolic disorders which may impair bone formation,

4. Osteomalacia,

5. Distant foci of infections which may spread to the implant site,

6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,

7. Vascular insufficiency, muscular atrophy, neuromuscular disease,

8. Incomplete or deficient soft tissue surrounding the knee.

Related Conditions & MeSH terms

• Arthritis
• Pain

Locations

Country	Name	City	State
United States	Physicians Clinic of Iowa	Cedar Rapids	Iowa
United States	OrthoCarolina Research Institute	Charlotte	North Carolina
United States	Midwest Orthopedics at RUSH University	Chicago	Illinois
United States	Geisinger Health System	Danville	Pennsylvania
United States	Stanford University, Department of Orthopedics	Stanford	California
United States	Jordan-Young Institute	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score		5 years
Secondary	Survivorship		5 years/ patient