A Study of Participants Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint
NCT ID: NCT05415592
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2023-03-31
2030-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DePuy Synthes Radial Head Replacement System
Participants will undergo a radial head replacement or partial replacement of the elbow joint with the DePuy Synthes Radial Head Replacement System.
DePuy Synthes Radial Head Replacement System
DePuy Synthes Radial Head Replacement System will be used for radial head replacement or partial replacement of the elbow joint.
Interventions
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DePuy Synthes Radial Head Replacement System
DePuy Synthes Radial Head Replacement System will be used for radial head replacement or partial replacement of the elbow joint.
Eligibility Criteria
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Inclusion Criteria
* Participant, who in the opinion of the Investigator, is able to understand the purpose of the study and is willing to return for all the required post-operative standard of care follow-up visits and have their data collected
* Participant who is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
Any one of below:
* Primary replacement after fracture of the radial head
* Participant needing a partial radial head replacement for degenerative or post-traumatic conditions presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: i) joint destruction and/or subluxation visible on x-ray and/or ii. resistance to conservative treatment
* Symptomatic sequelae after radial head resection
* Revision following failed radial head arthroplasty
Exclusion Criteria
* Rheumatoid arthritis
* Infection, sepsis, and osteomyelitis
* Uncooperative participant or participant with neurologic disorders who is incapable of following directions, osteoporosis, metabolic disorders which may impair bone formation, osteomalacia, distant foci of infections which may spread to the implant site, rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Participants with limited life expectancy due to significant medical co-morbidity
* Presence of major vascular or major nerve injury (radial, ulnar, medial, musculocutaneous)
* Women who are pregnant or lactating
* Unable to comply with study requirements example, with maintaining follow-up
* Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims
* Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months
* Demented or unable to provide informed consent
* Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete participant reported questionnaires or be compliant with follow-up requirements
22 Years
ALL
No
Sponsors
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DePuy Synthes Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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DePuy Synthes Products, Inc. Clinical Trial
Role: STUDY_DIRECTOR
DePuy Synthes Products, Inc.
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Slocum Research & Education Foundation
Eugene, Oregon, United States
Inova Orthopaedics - Fairfax
Falls Church, Virginia, United States
Glasgow Royal Infirmary (NHS Greater Glasgow & Clyde)
Glasgow, , United Kingdom
Countries
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References
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Agyeman KD, Damodar D, Watkins I, Dodds SD. Does radial head implant fixation affect functional outcomes? A systematic review and meta-analysis. J Shoulder Elbow Surg. 2019 Jan;28(1):126-130. doi: 10.1016/j.jse.2018.07.032. Epub 2018 Oct 17.
Bahreini M, Safaie A, Mirfazaelian H, Jalili M. How much change in pain score does really matter to patients? Am J Emerg Med. 2020 Aug;38(8):1641-1646. doi: 10.1016/j.ajem.2019.158489. Epub 2019 Nov 4.
Bain, G., Eygendaal, D., and van Riet, R. (2020). Surgical Techniques for Trauma and Sports Related Injuries of the Elbow
Broberg MA, Morrey BF. Results of delayed excision of the radial head after fracture. J Bone Joint Surg Am. 1986 Jun;68(5):669-74.
Churchill RW, Munoz J, Ahmad CS. Osteochondritis dissecans of the elbow. Curr Rev Musculoskelet Med. 2016 Jun;9(2):232-9. doi: 10.1007/s12178-016-9342-y.
Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
Cusick MC, Bonnaig NS, Azar FM, Mauck BM, Smith RA, Throckmorton TW. Accuracy and reliability of the Mayo Elbow Performance Score. J Hand Surg Am. 2014 Jun;39(6):1146-50. doi: 10.1016/j.jhsa.2014.01.041. Epub 2014 Mar 20.
Devlin NJ, Shah KK, Feng Y, Mulhern B, van Hout B. Valuing health-related quality of life: An EQ-5D-5L value set for England. Health Econ. 2018 Jan;27(1):7-22. doi: 10.1002/hec.3564. Epub 2017 Aug 22.
Duckworth AD, McQueen MM, Ring D. Fractures of the radial head. Bone Joint J. 2013 Feb;95-B(2):151-9. doi: 10.1302/0301-620X.95B2.29877.
Fowler JR, Goitz RJ. Radial head fractures: indications and outcomes for radial head arthroplasty. Orthop Clin North Am. 2013 Jul;44(3):425-31, x. doi: 10.1016/j.ocl.2013.03.013. Epub 2013 Apr 17.
Gao Y, Zhang W, Duan X, Yang J, Al-Qwbani M, Lv J, Xiang Z. Surgical interventions for treating radial head fractures in adults. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008987. doi: 10.1002/14651858.CD008987.pub2.
Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30.
Giannicola G, Sacchetti FM, Antonietti G, Piccioli A, Postacchini R, Cinotti G. Radial head, radiocapitellar and total elbow arthroplasties: a review of recent literature. Injury. 2014 Feb;45(2):428-36. doi: 10.1016/j.injury.2013.09.019. Epub 2013 Sep 19.
GmbH, S. (2020). Instructions for Use - Radial Head Replacement System (https://ifu.depuysynthes.com/?lang=en&archive=&keyword=Radial+Head).
Grewal R, MacDermid JC, Faber KJ, Drosdowech DS, King GJ. Comminuted radial head fractures treated with a modular metallic radial head arthroplasty. Study of outcomes. J Bone Joint Surg Am. 2006 Oct;88(10):2192-200. doi: 10.2106/JBJS.E.00962.
Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.
Heijink A, Kodde IF, Mulder PGH, Veltman ES, Kaas L, van den Bekerom MPJ, Eygendaal D. Radial Head Arthroplasty: A Systematic Review. JBJS Rev. 2016 Oct 18;4(10):e3. doi: 10.2106/JBJS.RVW.15.00095.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Jung M, Groetzner-Schmidt C, Porschke F, Grutzner PA, Guehring T, Schnetzke M. Low return-to-sports rate after elbow injury and treatment with radial head arthroplasty. J Shoulder Elbow Surg. 2019 Aug;28(8):1441-1448. doi: 10.1016/j.jse.2019.03.014. Epub 2019 Jun 18.
Kaas L, van Riet RP, Vroemen JP, Eygendaal D. The epidemiology of radial head fractures. J Shoulder Elbow Surg. 2010 Jun;19(4):520-3. doi: 10.1016/j.jse.2009.10.015. Epub 2010 Feb 10.
Lamas C, Castellanos J, Proubasta I, Dominguez E. Comminuted radial head fractures treated with pyrocarbon prosthetic replacement. Hand (N Y). 2011 Mar;6(1):27-33. doi: 10.1007/s11552-010-9282-8. Epub 2010 Jun 15.
Lapner M, King GJ. Radial head fractures. J Bone Joint Surg Am. 2013 Jun 19;95(12):1136-43. No abstract available.
MacDermid, J., Solomon, G., Valdes, K., and American Society of Hand, T. (2015). Clinical assessment recommendations
Mansat P. Surgical treatment of the rheumatoid elbow. Joint Bone Spine. 2001 May;68(3):198-210. doi: 10.1016/s1297-319x(01)00273-1.
Merolla G, Buononato C, Chillemi C, Paladini P, Porcellini G. Arthroscopic joint debridement and capsular release in primary and post-traumatic elbow osteoarthritis: a retrospective blinded cohort study with minimum 24-month follow-up. Musculoskelet Surg. 2015 Sep;99 Suppl 1:S83-90. doi: 10.1007/s12306-015-0365-0. Epub 2015 May 10.
Murphy, A. Elbow (Coyle's view) (Radiopaedia)
Skytta ET, Eskelinen A, Paavolainen P, Ikavalko M, Remes V. Total elbow arthroplasty in rheumatoid arthritis: a population-based study from the Finnish Arthroplasty Register. Acta Orthop. 2009 Aug;80(4):472-7. doi: 10.3109/17453670903110642.
Synthes, D. (2020a). Instructions for Use - Radial Head Replacement System
Synthes, D. (2020b). Radial Head Replacement System Surgical Technique
Synthes, D. (2020c). Radial Head Replacement System Surgical Technique Guide, pp. Surgical Technique Guide
Tarallo L, Mugnai R, Rocchi M, Capra F, Catani F. Mason type III radial head fractures treated by anatomic radial head arthroplasty: Is this a safe treatment option? Orthop Traumatol Surg Res. 2017 Apr;103(2):183-189. doi: 10.1016/j.otsr.2016.10.017. Epub 2016 Dec 8.
Other Identifiers
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DST202002
Identifier Type: OTHER
Identifier Source: secondary_id
DST202002
Identifier Type: -
Identifier Source: org_study_id
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