Knee Osteoarthritis Clinical Trial
Official title:
The Tritanium Uncemented Prosthesis Versus the Cemented Triathlon Prosthesis
NCT number | NCT04040764 |
Other study ID # | 2003957 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 15, 2019 |
Est. completion date | May 2023 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - A past history of tibial or femoral osteotomy surgery |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Devon and Exeter NHS Foundation Trust Hospital | Exeter | Devon |
Lead Sponsor | Collaborator |
---|---|
Royal Devon and Exeter NHS Foundation Trust | University of Exeter |
United Kingdom,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 6 weeks and 6 months post-op. | |
Secondary | Oxford Knee Score: Patient reported outcome measure (PROM) | The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty. The OKS consists of twelve questions covering function and pain associated with the knee. It has a scoring range of between 0-48 with the lowest score indicating the worst possible outcome and the highest score the best. | Pre-operatively, 6 weeks post op, 6 and 12 months post op. | |
Secondary | The Forgotten Joint Score (FJS): Patient reported outcome measure (PROM) | The FJS will focus on the patients' awareness of their joint replacement during a range of day to day and recreational activities. It is a validated PROM and consists of 12 questions where subjects are asked to rate their awareness of their joint replacement during various activities. The range of scoring is from 0-100, high scores indicate good outcome, that is, a high degree of forgetting the joint. | Pre-operatively, 6 weeks post op, 6 and 12 months post op. | |
Secondary | The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient reported outcome measure (PROM) | The KOOS questionnaire is designed to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardised answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. | Pre-operatively, 6 weeks post op, 6 and 12 months post op. | |
Secondary | EQ5D: Patient reported outcome measure (PROM) | The EQ5D PROM will be used as a measure of health-related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This will be used as a quantitative measure of health outcome that reflects the patient's own judgement. | Pre-operatively, 6 weeks post op, 6 and 12 months post op. | |
Secondary | Hospital Anxiety and Depression Scale (HADS): Patient reported outcome measure (PROM) | The HADS PROM will be used to determine levels of anxiety and depression in participants. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression with higher numbers depicting higher levels of anxiety and depression. | Pre-operatively, 6 weeks post op, 6 and 12 months post op. |
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