Two Year Study With Robotic-Arm Assisted Hip Surgery.

Surgery Clinical Trial

Official title:

A Two Year Multicenter Study of Robotic-Arm Assisted THA: Acetabular Cup Placement Accuracy and Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891199
• Other study ID #: 1808218345
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2023
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The incidence of dislocation following total hip arthroplasty (THA) has been reported to be from 1% to as much as 3.2%. The demand for THA is expected to increase. Post- dislocation solutions include closed reduction, open reduction, THA revision, and constrained cup, conversion to hemiarthroplasty, allograft or girdlestone resection. These solutions are often costly, painful and can involve substantial additional risks and complications. Acetabular cup placement is an important factor in the stability of the THA. Cup malpositioning has been associated with bearing surface ware and dislocation. For most patients, acceptable angles for abduction are 40° abduction (±10°) and 20° (±5°) version. However, malpositioning continues to occur resulting in cup angles outside acceptable ranges and leaving patients with an increased risk of dislocation.

This objective of this study is to 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients requiring primary total hip arthroplasty

2. Patients willing and able to comply with follow-up requirements

3. Patients willing to sign an Institutional Review Board approved informed consent form.

Exclusion Criteria:

1. Patients with Body Mass Index >45

2. Patients who are <18 years of age

3. Patients with an active infection or suspected latent infection in or about the hip joint

4. Bone stock that is inadequate for support or fixation of the prosthesis

5. Previous major hip surgery excluding hip arthroscopy

6. Total hip arthroplasty using cement fixation or resurfacing

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip
• Surgery

Intervention

Procedure:
• Robotic-Arm Assisted THA
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.

Locations

Country	Name	City	State
United States	WVU Medicine	Morgantown	West Virginia

Sponsors (3)

Lead Sponsor	Collaborator
West Virginia University	Stryker Nordic, West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Adherence to Lewinnek Safe Zone	5-25 degrees of anteversion; 30-50 degrees of inclination.	6 month