Two Year Study With Robotic-Arm Assisted Hip Surgery.

NCT03891199 | Completed Results

• 1 other identifier: 1808218345
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.

Conditions

Surgery; Hip Osteoarthritis

Keywords

clinical trial; randomization; hip arthroplasty

Outcome Measures

Primary Outcomes (5)

• Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version.

  Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.

  6 months

• Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period.

  The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up.

  1 Year

• Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period.

  The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in "general" and 3 questions assess emotional problems, fatigue and pain in the last 7 days. PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health)

  1year

• Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination.

  Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.

  6 months

• Adherence to Lewinnek Safe Zone

  5-25 degrees of anteversion; 30-50 degrees of inclination.

  6 month

Study Arms (2)

Control

NO INTERVENTION

Traditional THA.

Intervention

ACTIVE COMPARATOR

Robotic-arm assisted THA.

Procedure: Robotic-Arm Assisted THA

Interventions

Robotic-Arm Assisted THA PROCEDURE

The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring primary total hip arthroplasty
• Patients willing and able to comply with follow-up requirements
• Patients willing to sign an Institutional Review Board approved informed consent form.

You may not qualify if:

• Patients with Body Mass Index \>45
• Patients who are \<18 years of age
• Patients with an active infection or suspected latent infection in or about the hip joint
• Bone stock that is inadequate for support or fixation of the prosthesis
• Previous major hip surgery excluding hip arthroscopy
• Total hip arthroplasty using cement fixation or resurfacing

Sponsors & Collaborators

• West Virginia University: lead
• Stryker Nordic: collaborator
• West Penn Allegheny Health System: collaborator

Study Sites (1)

WVU Medicine

Morgantown, West Virginia, 26501, United States

Location

Related Publications (19)

• Banerjee S, Cherian JJ, Elmallah RK, Pierce TP, Jauregui JJ, Mont MA. Robot-assisted total hip arthroplasty. Expert Rev Med Devices. 2016;13(1):47-56. doi: 10.1586/17434440.2016.1124018. Epub 2015 Dec 21.

  PMID: 26592900 BACKGROUND

• Elson L, Dounchis J, Illgen R, Marchand RC, Padgett DE, Bragdon CR, Malchau H. Precision of acetabular cup placement in robotic integrated total hip arthroplasty. Hip Int. 2015 Nov-Dec;25(6):531-6. doi: 10.5301/hipint.5000289. Epub 2015 Sep 10.

  PMID: 26391264 BACKGROUND

• Kanawade V, Dorr LD, Banks SA, Zhang Z, Wan Z. Precision of robotic guided instrumentation for acetabular component positioning. J Arthroplasty. 2015 Mar;30(3):392-7. doi: 10.1016/j.arth.2014.10.021. Epub 2014 Oct 22.

  PMID: 25453633 BACKGROUND

• Werner SD, Stonestreet M, Jacofsky DJ. Makoplasty and the accuracy and efficacy of robotic-assisted arthroplasty. Surg Technol Int. 2014 Mar;24:302-6.

  PMID: 24574012 BACKGROUND

• Tarwala R, Dorr LD. Robotic assisted total hip arthroplasty using the MAKO platform. Curr Rev Musculoskelet Med. 2011 Sep;4(3):151-6. doi: 10.1007/s12178-011-9086-7.

  PMID: 21728013 BACKGROUND

• Callanan MC, Jarrett B, Bragdon CR, Zurakowski D, Rubash HE, Freiberg AA, Malchau H. The John Charnley Award: risk factors for cup malpositioning: quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res. 2011 Feb;469(2):319-29. doi: 10.1007/s11999-010-1487-1.

  PMID: 20717858 BACKGROUND

• Woo RY, Morrey BF. Dislocations after total hip arthroplasty. J Bone Joint Surg Am. 1982 Dec;64(9):1295-306.

  PMID: 7142237 BACKGROUND

• Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am. 1978 Mar;60(2):217-20.

  PMID: 641088 BACKGROUND

• Domb BG, El Bitar YF, Sadik AY, Stake CE, Botser IB. Comparison of robotic-assisted and conventional acetabular cup placement in THA: a matched-pair controlled study. Clin Orthop Relat Res. 2014 Jan;472(1):329-36. doi: 10.1007/s11999-013-3253-7. Epub 2013 Aug 29.

  PMID: 23990446 BACKGROUND

• Banerjee S, Cherian JJ, Elmallah RK, Jauregui JJ, Pierce TP, Mont MA. Robotic-assisted knee arthroplasty. Expert Rev Med Devices. 2015;12(6):727-35. doi: 10.1586/17434440.2015.1086264. Epub 2015 Sep 12.

  PMID: 26365088 BACKGROUND

• Roche M. Robotic-assisted unicompartmental knee arthroplasty: the MAKO experience. Orthop Clin North Am. 2015 Jan;46(1):125-31. doi: 10.1016/j.ocl.2014.09.008.

  PMID: 25435041 BACKGROUND

• Soong M, Rubash HE, Macaulay W. Dislocation after total hip arthroplasty. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):314-21. doi: 10.5435/00124635-200409000-00006.

  PMID: 15469226 BACKGROUND

• Pellicci PM, Bostrom M, Poss R. Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res. 1998 Oct;(355):224-8. doi: 10.1097/00003086-199810000-00023.

  PMID: 9917607 BACKGROUND

• Ghelman B, Kepler CK, Lyman S, Della Valle AG. CT outperforms radiography for determination of acetabular cup version after THA. Clin Orthop Relat Res. 2009 Sep;467(9):2362-70. doi: 10.1007/s11999-009-0774-1. Epub 2009 Mar 10.

  PMID: 19277802 BACKGROUND

• Redmond JM, Gupta A, Hammarstedt JE, Petrakos A, Stake CE, Domb BG. Accuracy of Component Placement in Robotic-Assisted Total Hip Arthroplasty. Orthopedics. 2016 May 1;39(3):193-9. doi: 10.3928/01477447-20160404-06. Epub 2016 Apr 12.

  PMID: 27064781 BACKGROUND

• El Bitar YF, Stone JC, Jackson TJ, Lindner D, Stake CE, Domb BG. Leg-Length Discrepancy After Total Hip Arthroplasty: Comparison of Robot-Assisted Posterior, Fluoroscopy-Guided Anterior, and Conventional Posterior Approaches. Am J Orthop (Belle Mead NJ). 2015 Jun;44(6):265-9.

  PMID: 26046996 BACKGROUND

• Gupta A, Redmond JM, Hammarstedt JE, Petrakos AE, Vemula SP, Domb BG. Does Robotic-Assisted Computer Navigation Affect Acetabular Cup Positioning in Total Hip Arthroplasty in the Obese Patient? A Comparison Study. J Arthroplasty. 2015 Dec;30(12):2204-7. doi: 10.1016/j.arth.2015.06.062. Epub 2015 Jul 2.

  PMID: 26253480 BACKGROUND

• Bukowski BR, Anderson P, Khlopas A, Chughtai M, Mont MA, Illgen RL 2nd. Improved Functional Outcomes with Robotic Compared with Manual Total Hip Arthroplasty. Surg Technol Int. 2016 Oct 26;29:303-308.

  PMID: 27728953 BACKGROUND

• Kamara E, Robinson J, Bas MA, Rodriguez JA, Hepinstall MS. Adoption of Robotic vs Fluoroscopic Guidance in Total Hip Arthroplasty: Is Acetabular Positioning Improved in the Learning Curve? J Arthroplasty. 2017 Jan;32(1):125-130. doi: 10.1016/j.arth.2016.06.039. Epub 2016 Jun 29.

  PMID: 27499519 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Brock A. Lindsey, MD
• Organization: West Virginia University

blindsey@hsc.wvu.edu

304-293-1317

Study Officials

• Matthew J Dietz, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Chair

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 26, 2019
• Study Start: April 8, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The individual participant data (IPD) will be available from the beginning of enrollment until the manuscript is submitted and accepted
• Access Criteria: the study will utilize a digital imaging analysis program called the Martell Hip Analysis Suite (HAS, Chicago, IL) as well as Computed Tomography (CT) scans. Patient reported outcomes (HOOS, PROMIS10, Hip stability and return to function) will also be collected at specified intervals. Using CT Scans and HAS analysis allows for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis.

Locations

US (1)