Regenerex Tibial Tray Multi-Center Data Collection

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00859963
• Collaborator: (none)
• Enrollment: 102
• Locations: 6
• Duration (Months): 117
• Patients Per Site: 17
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain; Arthritis

Detailed Description

See Protocol

Study Design

• Study Type: Observational
• Actual Enrollment: 102 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Regenerex Tibial Tray Multi-Center Data Collection
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Outcome Measures

Primary Outcome Measures

1. Knee Society Score [5 years]

Secondary Outcome Measures

1. Survivorship [5 years/ patient]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University, Department of Orthopedics	Stanford	California	United States	94305
2	Midwest Orthopedics at RUSH University	Chicago	Illinois	United States	60612
3	Physicians Clinic of Iowa	Cedar Rapids	Iowa	United States	52403
4	OrthoCarolina Research Institute	Charlotte	North Carolina	United States	28207
5	Geisinger Health System	Danville	Pennsylvania	United States	17822
6	Jordan-Young Institute	Virginia Beach	Virginia	United States	23462

Sponsors and Collaborators

• Zimmer Biomet

Investigators

• Study Director: Jing Xie, PhD, Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT00859963
• Other Study ID Numbers: ORTHO.CR.ROWG2 (US 25)
• First Posted: Mar 11, 2009
• Last Update Posted: Oct 27, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Zimmer Biomet: Press fit tibial tray
• Additional relevant MeSH terms: Arthritis

Study Results

No Results Posted as of Oct 27, 2021