NexGen TM Tibia Clinical Outcomes Study

Rheumatoid Arthritis Clinical Trial

Official title:

NexGen® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the NexGen® TM Monoblock and Modular Tibias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272373
• Other study ID #: K.CR.I.G.16.34
• Status: Completed
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate clinical performance for the commercially available NexGen TM Monoblock Tibia and NexGen TM Modular Tibia used in primary cementless tibia total knee arthroplasty.

Description:

This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device, and adverse event data. This clinical study will include the NexGen TM Monoblock Tibia and NexGen TM Modular Tibia as 2 single-arms being analyzed separately.

The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years.

The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol.

The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon:

• No revisions for any reason

• Oxford Knee Score >38

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: March 31, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is at least 18 years of age.

2. Patient qualifies for a primary cementless tibia total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

2. Collagen disorders and/or avascular necrosis of the femoral condyle.

3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

4. Moderate valgus, varus, or flexion deformities.

5. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.

3. Patient has participated in the study-related Informed Consent process.

4. Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.

5. Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.

6. Independent of study participation, patient is a candidate for commercially available cementless NexGen TM tibial knee component, implanted in accordance with product labeling.

Exclusion Criteria:

1. Previous history of infection in the affected joint.

2. Active local or systemic infection that may affect the prosthetic joint.

3. Insufficient bone stock on femoral or tibial surfaces.

4. Skeletal immaturity.

5. Neuropathic arthropathy.

6. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.

7. A stable, painless arthrodesis in a satisfactory functional position.

8. Severe instability secondary to the absence of collateral ligament integrity.

9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.

10. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.

11. Patient is currently participating in any other surgical intervention studies or pain management studies.

12. Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).

13. Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.

Related Conditions & MeSH terms

• Arthritis
• Collagen Diseases
• Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle
• Moderate Valgus, Varus, or Flexion Deformities
• Necrosis
• Osteoarthritis
• Polyarthritis
• Post-traumatic Loss of Joint Configuration
• Rheumatic Diseases
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

Device:
• NexGen TM Monoblock Tibia
Primary cementless tibia total knee arthroplasty
• NexGen TM Modular Tibia
Primary cementless tibia total knee arthroplasty

Locations

Country	Name	City	State
United States	Woods Mill Orthopedics, Ltd	Chesterfield	Missouri
United States	Franciscan Health	Mooresville	Indiana
United States	Henry County Orthopedics and Sports Medicine	New Castle	Indiana
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pinehurst Surgical Clinic	Pinehurst	North Carolina
United States	LA BioMed at Harbor-UCLA Medical Center	Torrance	California
United States	Cornerstone Orthopaedics & Sports Medicine, P.C.	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Parameters	Radiograph assessments	2 years
Secondary	Oxford Knee Score	The Oxford Knee Score assesses function and pain after total knee arthroplasty.	2 years
Secondary	Revision Rate	Rate of the number of revisions for any reason	2 years