Clinical trial NCT03272373: NexGen TM Tibia Clinical Outcomes Study
Official title: NexGen® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the NexGen® TM Monoblock and Modular Tibias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Polyarthritis
Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle
Post-traumatic Loss of Joint Configuration
Moderate Valgus, Varus, or Flexion Deformities
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-09-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 single arms being analyzed separately
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Radiograph Assessment of Progressive Tibial Radiolucencies
timeFrame: 2 years
Secondary outcomes:
measure: Oxford Knee Score
timeFrame: 2 years
measure: Revision Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Torrance
country: United States
facility: LA BioMed at Harbor-UCLA Medical Center
state: California
city: Wheat Ridge
country: United States
facility: Cornerstone Orthopaedics & Sports Medicine, P.C.
state: Colorado
city: Mooresville
country: United States
facility: Franciscan Health
state: Indiana
city: New Castle
country: United States
facility: Henry County Orthopedics and Sports Medicine
state: Indiana
city: Chesterfield
country: United States
facility: Woods Mill Orthopedics, Ltd
state: Missouri
city: Pinehurst
country: United States
facility: Pinehurst Surgical Clinic
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Zimmer Biomet
name: Kacy Arnold, RN, MBA
role: STUDY_DIRECTOR
References: