Knee Arthroplasty, Total Clinical Trial
Official title:
Does Mini Mid-Vastus Approach Have An Advantageous Effect On Rapid Recovery Protocols Over Medial Parapatellar Approach In Total Knee Arthroplasty? A Prospective, Randomized, Single-Blinded Study
NCT number | NCT04450485 |
Other study ID # | 2018TIPF017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | July 30, 2019 |
Verified date | June 2020 |
Source | Pamukkale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Nowadays, due to the demands to improve life and health conditions of osteoarthritis patients, more effective surgical treatment methods are needed to obtain satisfactory results when performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence based multidisciplinary approaches targeted on multimodal patient care and primarily focused on enhancing rapid functional recovery of the patients. These protocols recommend use of minimal invasive approaches for TKA patients to enhance rapid recovery. Although studies in the literature has been reported similar results in medial para-patellar approach (MPP) and minimal invasive approaches in long terms, better surgical outcomes in short term in favor of minimal invasive approaches also encouraged fast-track protocol builders to prefer minimal invasive approaches. However, this recommendation is not evidence based and there is no study comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of pain, length of hospital stays and functional recovery in fast-track TKA patients. Therefore, we aimed to compare the effects of mini mid-vastus (MMV) and MPP approaches on postoperative clinical results (pain, quality of life, functional outcome, and length of hospital stay) in fast-track TKA patients, and to decide whether any additional achievements are obtained with MMV approach in this patient group.
Status | Completed |
Enrollment | 54 |
Est. completion date | July 30, 2019 |
Est. primary completion date | March 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients scheduled for unilateral TKA surgery due to primary OA - Patients capable of understanding verbal and written instructions. Exclusion Criteria: - Revision TKA surgery - ASA score >3 - previous major orthopedic surgery in either lower extremities - neurologic compromise - psychiatric problems - regular hypnotic and/or anxiolytic medication usage - dementia - patients participated in a particular physical activity program within the last 3 months. |
Country | Name | City | State |
---|---|---|---|
Turkey | Pamukkale University Medical Faculty | Denizli |
Lead Sponsor | Collaborator |
---|---|
Pamukkale University |
Turkey,
Chin PL, Foo LS, Yang KY, Yeo SJ, Lo NN. Randomized controlled trial comparing the radiologic outcomes of conventional and minimally invasive techniques for total knee arthroplasty. J Arthroplasty. 2007 Sep;22(6):800-6. Epub 2007 Apr 20. — View Citation
Dalury DF, Jiranek WA. A comparison of the midvastus and paramedian approaches for total knee arthroplasty. J Arthroplasty. 1999 Jan;14(1):33-7. — View Citation
Heekin RD, Fokin AA. Mini-midvastus versus mini-medial parapatellar approach for minimally invasive total knee arthroplasty: outcomes pendulum is at equilibrium. J Arthroplasty. 2014 Feb;29(2):339-42. doi: 10.1016/j.arth.2013.05.016. Epub 2013 Jun 19. — View Citation
Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593. Review. — View Citation
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Kazarian GS, Siow MY, Chen AF, Deirmengian CA. Comparison of Quadriceps-Sparing and Medial Parapatellar Approaches in Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials. J Arthroplasty. 2018 Jan;33(1):277-283. doi: 10.1016/j.arth.2017.08.025. Epub 2017 Aug 30. Review. — View Citation
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Nestor BJ, Toulson CE, Backus SI, Lyman SL, Foote KL, Windsor RE. Mini-midvastus vs standard medial parapatellar approach: a prospective, randomized, double-blinded study in patients undergoing bilateral total knee arthroplasty. J Arthroplasty. 2010 Sep;25(6 Suppl):5-11, 11.e1. doi: 10.1016/j.arth.2010.04.003. Epub 2010 Jun 11. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain preoperative | Visual Analog Scale used to assess pain | Baseline (preoperatively) | |
Primary | Pain postoperative 1 | Visual Analog Scale used to assess pain | at postoperative fourth weeks | |
Primary | Pain postoperative 2 | Visual Analog Scale used to assess pain | at postoperative twelfth weeks | |
Primary | Knee Range of Motion preoperative | Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion | Baseline (preoperatively) | |
Primary | Knee Range of Motion postoperative 1 | Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion | at postoperative fourth week | |
Primary | Knee Range of Motion postoperative 2 | Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion | at postoperative twelfth week | |
Primary | Quadriceps muscle strength preoperative | Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA) | Baseline (preoperatively) | |
Primary | Quadriceps muscle strength postoperative 1 | Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA) | at postoperative fourth weeks | |
Primary | Quadriceps muscle strength postoperative 2 | Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA) | at postoperative twelfth weeks | |
Primary | Patient-reported activity limitations preoperative | The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used | Baseline (preoperatively) | |
Primary | Patient-reported activity limitations postoperative 1 | The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used | at postoperative fourth weeks | |
Primary | Patient-reported activity limitations postoperative 2 | The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used | at postoperative twelfth weeks | |
Primary | Performance-based activity limitations-preoperative | 30-sec chair-stand test and stair-climb test are used | Baseline (preoperatively) | |
Primary | Performance-based activity limitations- postoperative 1 | 30-sec chair-stand test and stair-climb test are used | at postoperative fourth weeks | |
Primary | Performance-based activity limitations - postoperative 2 | 30-sec chair-stand test and stair-climb test are used | at postoperative twelfth weeks | |
Primary | Quality of life-preoperative | Short Form-36 (SF-36) is used | Baseline (preoperatively) | |
Primary | Quality of life-preoperative- postoperative 1 | Short Form-36 (SF-36) is used | at postoperative fourth weeks | |
Primary | Quality of life-preoperative- postoperative 2 | Short Form-36 (SF-36) is used | at postoperative twelfth weeks | |
Primary | Length of hospital stay | Length of hospital stay is measured beginning from the hospitalization of the patient and ending at discharge of the patients (unit-hours) | through study completion, an average of 1 year | |
Secondary | Length of operation time | Length of operation time is measured in minutes during the surgery | the surgery | |
Secondary | Amount of blood loss | Amount of blood loss is measured from the suction drainage (unit-milliliters) | through study completion, an average of 1 year | |
Secondary | postoperative component alignments | Long leg radiographs of the patients are evaluated postoperatively by using a digital orthopedic templating software-Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium). | through study completion, an average of 1 year |
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