A Comparison of Total Knee Replacement Patients Using the Zimmer-Biomet Persona Total Knee System With Different Inserts

NCT04643119 | Unknown

• 1 other identifier: 2020/2866
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

As demand for knee joint arthroplasties surge, improving long term patients' satisfaction and implant survivorship has become of utmost importance, as patients seek not only to alleviate their condition, but also return to their usual daily activities and sports. Implant type and design plays an important role in this, with many modern designs seeking to replicate the native knee's kinematics and alignment through mimicry of native knee biomechanics in its femoral components, tibial components, and polyethylene bearing inserts. The Zimmer-Biomet Persona® Total Knee Cruciate-Retaining Femoral Component (CR Femur), used in conjunction with the kinematic alignment surgical technique, has been shown to produce better functional outcomes and improved patient satisfaction following total knee arthroplasty. More recently, Zimmer-Biomet introduced the Medial Congruent Bearing (MC Bearing) design to be used with the CR Femur; the design facilitates greater stability through increased anterior lip height compared to the original Cruciate Retaining Bearing (CR Bearing), thus allowing for greater anterior constraint and subluxation resistance that aids in activities requiring deeper flexion or full extension. However, the evidence that this will lead to better patient satisfaction and function is scarce, and requires further study to prove that the MC Bearing is a better insert choice to recommend to both surgeons and patients alike. 120 patients from Singapore General Hospital seeking primary total knee replacement surgery will be recruited for this study, and randomised in a 1:1 ratio to receive either the CR Bearing or the MC Bearing alongside the Zimmer-Biomet CR Femur implant. They will be followed up for two years post-operatively, and their outcomes recorded at specific milestones to be analysed for the impact of insert design on knee function, patient satisfaction and quality of life post-surgery.

Conditions

Osteoarthritis, Knee; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Comparison of Oxford Knee Scores between treatment groups

  Differences in total Oxford Knee Scores between the two treatment groups will be compared at 1-month, 3-months, 6-months, 12-months and 24-months post-operatively.

  2 years

• Comparison of Knee Society Rating Scores between treatment groups

  Differences in total Knee Society Rating Scores between the two treatment groups will be compared at 1-month, 3-months, 6-months, 12-months and 24-months post-operatively.

  2 years

• Comparison of Forgotten Joint Scores between treatment groups

  Differences in total Forgotten Joint- 12 Item Scores between the two treatment groups will be compared at 1-month, 3-months, 6-months, 12-months and 24-months post-operatively.

  2 years

• Comparison of UCLA Activity scores between treatment groups

  Differences in total UCLA Activity scores between the two treatment groups will be compared at 1-month, 3-months, 6-months, 12-months and 24-months post-operatively.

  2 years

Secondary Outcomes (3)

• Comparison of discharge times between treatment groups

  2 years

• Comparison of quality of life between treatment groups

  2 years

• Comparison of gait in pre-operative and post-operative state

  2 years

Study Arms (2)

Cruciate-Retaining Insert

ACTIVE COMPARATOR

Device: Cruciate-Retaining Insert

Medial-Congruent Insert

EXPERIMENTAL

Device: Medial Congruent Insert

Interventions

Medial Congruent Insert DEVICE

The Medial Congruent Bearing (MC Bearing) design was introduced in 2016 for use with the Zimmer-Persona Cruciate-Retaining Femur: the design facilitates greater stability through increased anterior lip height compared to the original Cruciate Retaining Bearing (CR Bearing), allowing for greater anterior constraint and subluxation resistance that aids in full extension and deep flexion. Furthermore, the MC Bearing has been suggested for use in patients presenting with more complicated surgical histories (e.g prior high tibial osteotomies or patellectomies), whereas the original CR Bearing is strictly suggested for use only in patients undergoing knee surgery for the first time, where the posterior cruciate ligament may still be intact.

Medial-Congruent Insert

Cruciate-Retaining Insert DEVICE

The Cruciate-Retaining Bearing (CR Bearing) design was launched together with the use of the Cruciate-Retaining Femoral Components (CR Femur) of the Zimmer-Biomet Persona® Total Knee system. The design not only stabilises the knee through medial conformity and anterior constraint, but also allows for freer and more natural deep flexion through freer movement of the lateral condyle.

Cruciate-Retaining Insert

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with, or are experiencing knee osteoarthritis
• Patients considered fit and appropriate for TKA surgical intervention
• Patients between 50-80 years of age at time of surgery
• Patients of Chinese, Malay, or Indian ethnicity (combination of the three groups are accepted)
• Patient must be capable of giving informed consent and agree to comply with the postoperative review programme
• Patients who will stay in Singapore for up to two years post-surgery
• Patients should have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
• Female patients should be post-menopausal, or be willing to take contraceptives/birth control measures throughout study

You may not qualify if:

• Patients not suitable for routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis
• Patient has bone loss that requires augmentation
• Patients determined medically unfit for surgical intervention
• Patients who had prior knee replacement surgery done for the symptomatic limb
• Patients with impaired musculoskeletal function
• Patients less than 50 years of age or greater than 80 years of age
• Patients enrolled on another concurrent clinical trial
• Patients who are not local residents, or do not intend to stay in Singapore after surgery

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lincoln Liow

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lincoln Liow

CONTACT

+65 63214047; dr.lincoln.liow@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients are randomised to 2 different treatment groups by a study team member who will not participate in final data analysis; only their surgeon and the clinical team will be aware of the treatment the patient undergoes. Treatment codes will be used to indicate the patient's treatment assignment in study-related documents, and clinical documents will reference their treatment code as well. Radiological, functional and strength assessments will be conducted by non-study clinical staff who will not be aware of the patient's treatment group. Analysis will be conducted by a statistician who is uninvolved in the recruitment and data collection process, and only upon completion will the treatment arms will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: November 24, 2020
• Study Start: April 26, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)