Uncemented Tritanium TKR vs Cemented Triathlon TKR

NCT04040764 | Active Not Recruiting DMC

• 1 other identifier: 2003957
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The Study aims to investigate whether there is a clinically important difference in peri-articular bone mineral density (BMD) and trabecular bone score (TBS) between patients undergoing two different types of knee replacement fixation - uncemented Tritanium total knee replacement (TKR) and cemented Triathlon TKR. Before undertaking a full randomised control trial however, it is necessary to establish that the proposed methodology and approach are feasible. Therefore an internal pilot study will be performed first. This registration is for the internal pilot study.

Conditions

Knee Osteoarthritis

Keywords

Knee replacement

Outcome Measures

Primary Outcomes (1)

• Assessment and comparison of Trabecular Bone Score (TBS) between patients undergoing two different types of knee replacement fixation - uncemented Tritanium knee replacement and cemented Triathlon knee replacement.

  We plan to compareTBS data between patients randomised to the 2 arms of the trial: the uncemented Tritanium and cemented Triathlon total knee replacement. TBS is a texture parameter that evaluates gray-level pixel-by-pixel variations and provides an assessment of fracture risk. TBS is calculated from patients DEXA scan results and is in a numerical format. Baseline TBS scores will be calculated from pre-operative DEXA scans and will be compared to post op scores. Any differences in TBS scores will be compared between participants in the 2 arms of the trial.

  Our primary outcome is TBS scores at 12 months post total knee replacement

Secondary Outcomes (6)

• Assessment and comparison of Trabecular Bone Score (TBS) between patients undergoing two different types of knee replacement fixation - Uncemented Tritanium knee replacement and cemented Triathlon knee replacement.

  6 weeks and 6 months post-op.

• Oxford Knee Score: Patient reported outcome measure (PROM)

  Pre-operatively, 6 weeks post op, 6 and 12 months post op.

• The Forgotten Joint Score (FJS): Patient reported outcome measure (PROM)

  Pre-operatively, 6 weeks post op, 6 and 12 months post op.

• The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient reported outcome measure (PROM)

  Pre-operatively, 6 weeks post op, 6 and 12 months post op.

• EQ5D: Patient reported outcome measure (PROM)

  Pre-operatively, 6 weeks post op, 6 and 12 months post op.

Study Arms (2)

Uncemented Tritanium Knee Replacement

EXPERIMENTAL

30 participants will be randomly allocated to receive an uncemented Tritanium total knee replacement.

Procedure: Tritanium uncemented Total Knee Replacement

Cemented Triathlon Knee Replacement

ACTIVE COMPARATOR

30 participants will be randomly allocated to receive standard Triathlon cemented total knee replacements.

Procedure: Tritanium uncemented Total Knee Replacement

Interventions

Tritanium uncemented Total Knee Replacement PROCEDURE

This will be an internal pilot study in which patients will be blinded and randomly assigned to 1 of 2 arms with 30 patients in each arm. The first arm will receive a Triathlon knee replacement device which is cemented into place. The second arm will receive an uncemented Triathlon Tritanium TKR.

Also known as: Triathlon Cemented Total Knee Replacement

Cemented Triathlon Knee Replacement; Uncemented Tritanium Knee Replacement

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary TKR at the RD+E Hospital
• Patients must have completed a consent form for the study
• Patients must be prepared to comply with the pre and post-operative investigations, attendance schedule and questionnaire schedule of the study
• If the knee for surgery is suitable for standard condylar TKR components
• The diagnosis is of tricompartmental osteoarthritis of the knee
• Aged 50-70 years at time of surgery

You may not qualify if:

• Refusal to consent to the study
• If the knee for surgery is not suitable for standard condylar TKR.
• Pregnancy
• Prisoners
• A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the assessment schedules
• Patients unable to read or understand the patient information leaflet and consent form
• Patients who have a Body Mass Index (BMI) ≥ 38
• Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation
• Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year
• Patient requires bilateral total knee replacements, or has a history of unsuccessful contralateral partial or total knee replacement
• Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device
• Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration
• Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days)
• Patients currently taking bisphosphonate medication or have taken within the previous 10 years
• The presence of peri-articular cysts evident on the pre-operative x-ray such as could compromise the stability at the bone implant interface if the uncemented component is used

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• University of Exeter: collaborator

Study Sites (1)

Royal Devon and Exeter NHS Foundation Trust Hospital

Exeter, Devon, EX2 5DW, United Kingdom

Location

Related Publications (6)

• Fricka KB, Sritulanondha S, McAsey CJ. To Cement or Not? Two-Year Results of a Prospective, Randomized Study Comparing Cemented Vs. Cementless Total Knee Arthroplasty (TKA). J Arthroplasty. 2015 Sep;30(9 Suppl):55-8. doi: 10.1016/j.arth.2015.04.049. Epub 2015 Jun 3.

  PMID: 26118567 BACKGROUND

• Gundry M, Hopkins S, Knapp K. A Review on Bone Mineral Density Loss in Total Knee Replacements Leading to Increased Fracture Risk. Clin Rev Bone Miner Metab. 2017;15(4):162-174. doi: 10.1007/s12018-017-9238-4. Epub 2017 Oct 27.

  PMID: 29213219 BACKGROUND

• Minoda Y, Kobayashi A, Ikebuchi M, Iwaki H, Inori F, Nakamura H. Porous tantalum tibial component prevents periprosthetic loss of bone mineral density after total knee arthroplasty for five years-a matched cohort study. J Arthroplasty. 2013 Dec;28(10):1760-4. doi: 10.1016/j.arth.2013.03.031. Epub 2013 Apr 30.

  PMID: 23642446 BACKGROUND

• Winther N, Jensen C, Petersen M, Lind T, Schroder H, Petersen M. Changes in bone mineral density of the proximal tibia after uncemented total knee arthroplasty. A prospective randomized study. Int Orthop. 2016 Feb;40(2):285-94. doi: 10.1007/s00264-015-2852-1. Epub 2015 Jul 17.

  PMID: 26183139 BACKGROUND

• Abu-Rajab RB, Watson WS, Walker B, Roberts J, Gallacher SJ, Meek RM. Peri-prosthetic bone mineral density after total knee arthroplasty. Cemented versus cementless fixation. J Bone Joint Surg Br. 2006 May;88(5):606-13. doi: 10.1302/0301-620X.88B5.16893.

  PMID: 16645105 BACKGROUND

• Nam D, Kopinski JE, Meyer Z, Rames RD, Nunley RM, Barrack RL. Perioperative and Early Postoperative Comparison of a Modern Cemented and Cementless Total Knee Arthroplasty of the Same Design. J Arthroplasty. 2017 Jul;32(7):2151-2155. doi: 10.1016/j.arth.2017.01.051. Epub 2017 Feb 7.

  PMID: 28238584 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Ben Waterson, MD

  Royal Devon and Exeter NHS Foundation Trust Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The following people will be blinded as to which arm of the study the patient is allocated to: * The patient * The statistician who performs the analysis of the results * The radiographer reporting upon the DXA scan results
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An internal pilot study comparing 2 different types of knee prosthesis; uncemented vs cemented total knee replacement

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: August 1, 2019
• Study Start: October 15, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)