Surgical Approach in Fast Track Knee Arthroplasty

NCT04450485 | Completed

• 1 other identifier: 2018TIPF017
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Arthroplasty, Total

Keywords

Total knee arthroplasty; Surgical approach; Fast track

Outcome Measures

Primary Outcomes (19)

• Pain preoperative

  Visual Analog Scale used to assess pain

  Baseline (preoperatively)

• Pain postoperative 1

  Visual Analog Scale used to assess pain

  at postoperative fourth weeks

• Pain postoperative 2

  Visual Analog Scale used to assess pain

  at postoperative twelfth weeks

• Knee Range of Motion preoperative

  Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion

  Baseline (preoperatively)

• Knee Range of Motion postoperative 1

  Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion

  at postoperative fourth week

• Knee Range of Motion postoperative 2

  Digital goniometer (HALO Medical Devices, Australia) used to assess knee range of motion

  at postoperative twelfth week

• Quadriceps muscle strength preoperative

  Quadriceps muscle strength is measured (unit=newton(N)) with hand-held dynamometer (Commander Muscle Tester, J Tech, USA)

  Baseline (preoperatively)

• 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

• 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

• Patient-reported activity limitations preoperative

  The Western Ontario and McMaster Universities Arthritis Index and Knee injury and Osteoarthritis Outcome Score are used

  Baseline (preoperatively)

• 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

• 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

• Performance-based activity limitations-preoperative

  30-sec chair-stand test and stair-climb test are used

  Baseline (preoperatively)

• Performance-based activity limitations- postoperative 1

  30-sec chair-stand test and stair-climb test are used

  at postoperative fourth weeks

• Performance-based activity limitations - postoperative 2

  30-sec chair-stand test and stair-climb test are used

  at postoperative twelfth weeks

• Quality of life-preoperative

  Short Form-36 (SF-36) is used

  Baseline (preoperatively)

• Quality of life-preoperative- postoperative 1

  Short Form-36 (SF-36) is used

  at postoperative fourth weeks

• Quality of life-preoperative- postoperative 2

  Short Form-36 (SF-36) is used

  at postoperative twelfth weeks

• 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 Outcomes (3)

• Length of operation time

  the surgery

• Amount of blood loss

  through study completion, an average of 1 year

• postoperative component alignments

  through study completion, an average of 1 year

Study Arms (2)

Medial para-patellar approach

ACTIVE COMPARATOR

Fast track protocol applied total knee arthroplasty patients operated by using medial para-patellar approach

Procedure: Total knee arthroplasty

Mini mid-vastus approach

ACTIVE COMPARATOR

Fast track protocol applied total knee arthroplasty patients operated by using mini mid-vastus approach

Procedure: Total knee arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

Total knee arthroplasty

Medial para-patellar approach; Mini mid-vastus approach

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for unilateral TKA surgery due to primary OA
• Patients capable of understanding verbal and written instructions.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Medical Faculty

Denizli, 20070, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 23205862 BACKGROUND

• Stowers MD, Manuopangai L, Hill AG, Gray JR, Coleman B, Munro JT. Enhanced Recovery After Surgery in elective hip and knee arthroplasty reduces length of hospital stay. ANZ J Surg. 2016 Jun;86(6):475-9. doi: 10.1111/ans.13538. Epub 2016 Mar 28.

  PMID: 27018137 BACKGROUND

• 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.

  PMID: 23790343 BACKGROUND

• Karpman RR, Smith HL. Comparison of the early results of minimally invasive vs standard approaches to total knee arthroplasty: a prospective, randomized study. J Arthroplasty. 2009 Aug;24(5):681-8. doi: 10.1016/j.arth.2008.03.011. Epub 2008 Jun 6.

  PMID: 18538536 BACKGROUND

• 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. doi: 10.1016/j.arth.2006.10.009. Epub 2007 Apr 20.

  PMID: 17826268 BACKGROUND

• Dalury DF, Jiranek WA. A comparison of the midvastus and paramedian approaches for total knee arthroplasty. J Arthroplasty. 1999 Jan;14(1):33-7. doi: 10.1016/s0883-5403(99)90199-7.

  PMID: 9926950 BACKGROUND

• White RE Jr, Allman JK, Trauger JA, Dales BH. Clinical comparison of the midvastus and medial parapatellar surgical approaches. Clin Orthop Relat Res. 1999 Oct;(367):117-22.

  PMID: 10546605 BACKGROUND

• Stevens-Lapsley JE, Bade MJ, Shulman BC, Kohrt WM, Dayton MR. Minimally invasive total knee arthroplasty improves early knee strength but not functional performance: a randomized controlled trial. J Arthroplasty. 2012 Dec;27(10):1812-1819.e2. doi: 10.1016/j.arth.2012.02.016. Epub 2012 Mar 28.

  PMID: 22459124 BACKGROUND

• Lin WP, Lin J, Horng LC, Chang SM, Jiang CC. Quadriceps-sparing, minimal-incision total knee arthroplasty: a comparative study. J Arthroplasty. 2009 Oct;24(7):1024-32. doi: 10.1016/j.arth.2008.07.005. Epub 2008 Aug 30.

  PMID: 18757172 BACKGROUND

• 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.

  PMID: 20541889 BACKGROUND

• 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.

  PMID: 28947369 BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Harun R Gungor, MD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and outcomes assessor are blinded to the type of surgical approach.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associated Professor

Model Details: Patients planned for fast track protocol applied total knee arthroplasty randomized into two groups by a computer program to generate random numbers and assign participants to either to mini mid-vastus or medial para-patellar surgical approach group

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 29, 2020
• Study Start: May 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: July 30, 2019
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)