Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)

NCT03659318 | Completed Phase 4

• 1 other identifier: RoboTKA
• Study Type: interventional
• Target: 674
• Locations: 0 countries
• Sites: N/A

Brief Summary

Robotic-assisted total knee arthroplasty (TKA) was introduced to attempt to enhance the precision of bone preparation, component alignment and ultimately improve clinical results and survivorship of TKA. Although several published data suggest that bone preparation, and knee component alignment were improved by using robotic assistance, there is no high-quality evidence from randomized trials at long-term of which investigators are aware evaluating whether the improved bone preparation and knee component alignment improved clinical function or longevity of the TKA.

Conditions

Arthritis; Knee Arthropathy; Robotics

Outcome Measures

Primary Outcomes (1)

• Knee society Knee score

  a proven score for the measurement of knee function, the score ranges from 0 to 100, 100 being the best possible score, indicating normal knee function

  20 years after the surgery

Secondary Outcomes (1)

• WOMAC score

  20 years after the surgery

Study Arms (2)

Robot

EXPERIMENTAL

TKA is done with robotic-assisted manner. Final implantation of implants is done by surgeons, same as the conventional way. Robotic-assisted TKA for this arm.

Procedure: Robotic-assisted TKA

Conventional

ACTIVE COMPARATOR

TKA is done with conventional instruments. Conventional TKA for this arm.

Procedure: Conventional TKA

Interventions

Robotic-assisted TKA PROCEDURE

Total knee arthroplasty is carried out with help of robotic surgery system, using a Robodoc system. CT-based preoperative planning using ORTHODOC (Integrated Surgical Technology Corp) performed in the first step before the day of surgery, and the robotic-assisted surgery using the ROBODOC surgical assistance in the second step. The bone markers are registered to the computer, and the computer arm does all the cutting and preparation of bones. This is in contrast to conventional jigs and cutting blocks. Actual implantation of the implants is done by a surgeon. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.

Robot

Conventional TKA PROCEDURE

Total knee arthroplasty is carried out with classical, conventional, manual method. A surgeon measures the angle, length of the cuts with bone landmarks and specialized surgical instruments. After all the cuts actual implantation is done. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.

Conventional

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• end stage knee arthritis

You may not qualify if:

• mild knee deformity
• inflammatory arthritis
• foot and ankle disorder
• dementia
• hip disease
• history of a stroke
• older than 65 years of age

Sponsors & Collaborators

• Ewha Womans University: lead

Related Publications (6)

• Arima J, Whiteside LA, McCarthy DS, White SE. Femoral rotational alignment, based on the anteroposterior axis, in total knee arthroplasty in a valgus knee. A technical note. J Bone Joint Surg Am. 1995 Sep;77(9):1331-4. doi: 10.2106/00004623-199509000-00006.

  PMID: 7673281 BACKGROUND

• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

  PMID: 3068365 BACKGROUND

• Bellemans J, Vandenneucker H, Vanlauwe J. Robot-assisted total knee arthroplasty. Clin Orthop Relat Res. 2007 Nov;464:111-6. doi: 10.1097/BLO.0b013e318126c0c0.

  PMID: 17563698 BACKGROUND

• Crowder AR, Duffy GP, Trousdale RT. Long-term results of total knee arthroplasty in young patients with rheumatoid arthritis. J Arthroplasty. 2005 Oct;20(7 Suppl 3):12-6. doi: 10.1016/j.arth.2005.05.020.

  PMID: 16213997 BACKGROUND

• Decking J, Theis C, Achenbach T, Roth E, Nafe B, Eckardt A. Robotic total knee arthroplasty: the accuracy of CT-based component placement. Acta Orthop Scand. 2004 Oct;75(5):573-9. doi: 10.1080/00016470410001448.

  PMID: 15513489 BACKGROUND

• Jacofsky DJ, Allen M. Robotics in Arthroplasty: A Comprehensive Review. J Arthroplasty. 2016 Oct;31(10):2353-63. doi: 10.1016/j.arth.2016.05.026. Epub 2016 May 18.

  PMID: 27325369 BACKGROUND

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2018
• First Posted: September 6, 2018
• Study Start: January 1, 2002
• Primary Completion: February 1, 2008
• Study Completion: July 1, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07