Cemented vs Cementless in Bilateral TKA

• Sponsor: Thammasat University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04496102
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Total Knee Arthroplasty	Device: Triathlon	N/A

Detailed Description

To compare early functional outcomes, radiographic finding and operative time between cemented and cementless modern implant in sequential bilateral total kee arthroplasty.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial
• Actual Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cemented TKA Cemented TKA (Triathlon, Stryker) include patellar resurfacing	Device: Triathlon; Modern TKA design (Triathlon) with patellar resurfacing
Experimental: Cementless TKA Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing	Device: Triathlon; Modern TKA design (Triathlon) with patellar resurfacing

Outcome Measures

Primary Outcome Measures

1. Compare mean Forgotten joint score between 2 groups [at 1 year]

   The total score ranges from 0-100, where a high score is the best outcome

Secondary Outcome Measures

1. Operative time [intra-operative assessment]

2. modified the Western Ontario and McMaster Universities Osteoarthritis Index score [post-op 2, 6 week, 3, 6, 12 month]

   The total score ranges from 0-96, where a high score is the worse outcome

3. Pain level [Once daily 1-14 days after surgery then once a week until 3 months]

   VAS for pain (0-100)

4. Range of knee motion [post-op 2, 6 week, 3, 6, 12 month]

   flexion and extension (degrees) which measured by long goniometer

5. complication [until 1 year after surgery]

   such as fracture, infection, stiffness

6. Radiological finding [post-op 2, 6 week, 3, 6, 12 month]

   Radiolucent line at femoral, tibial and patellar components which measured from radiolucent intervals (measured in millimetres) between the cement or prostheses and the bone according to the knee society total knee arthroplasty roentgenographic evaluation and scoring system

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA status 1 or 2

• Diagnosed with bilateral osteoarthritis of the knees

• Participant understand and consent to the protocol of the trial

Exclusion Criteria:

• Morbid obesity (BMI >40)

• Inflammatory arthritis

• Osteoporosis

• Metabolic bone disease

• Bone defect that seen from radiographs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thammasat University	Khlong Luang	Pathum Thani	Thailand	12120

Sponsors and Collaborators

• Thammasat University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Supakit Kanitnate, Principal Investigator, Thammasat University
• ClinicalTrials.gov Identifier: NCT04496102
• Other Study ID Numbers: OrthoTU12
• First Posted: Aug 3, 2020
• Last Update Posted: Aug 3, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Supakit Kanitnate, Principal Investigator, Thammasat University: cemented; cementless; total knee arthroplasty; short term outcome; functional outcome
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Aug 3, 2020