RHEVOLUTION Clinical Trial: Use of Two Radial Head Arthroplasty Designs for the Treatment of Elbow Instability

NCT07560657 | Active Not Recruiting DMC

• 1 other identifier: EC 2026.041
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

RHEVOLUTION Clinical Trial: Radial Head Arthroplasty for the Treatment of Acute Traumatic Elbow Instability, a Randomized Trial Comparing Two Implant Desings Principal Investigator/collaborators: Dr. Raúl Barco, Dr. Blanca Diez Sánchez, Dr. Juan Ameztoy Gallego, Dr. Luis Palacios, Dr. Alfonso Vaquero-Picado and Dr. Samuel Antuña, Department: Orthopedic Surgery and Traumatology Institution: La Paz University Hospital Introduction: Participants are being invited to participate in a clinical research study. Our intention is to provide participants with clear and sufficient information so that participants may decide whether or not wish to participate. The investigators will answer any questions participants may have at any time. Participants may also discuss this information with anyone participants consider appropriate before making the decision. Voluntary Participation: Participants' participation in this study is entirely voluntary. Participants may decide not to participate or withdraw the consent at any time without providing any explanation. Participants' decision will not affect the relationship with the doctor nor the medical care it is received in any way. Study Description and Objectives: Participants are being invited to participate in a clinical study that aims to compare the outcomes of two elbow arthroplasties commonly used at our center to replace a portion of the elbow fractured by a fall that cannot be fixed. The fracture affects the radial head, and when fixation is not viable, the radial head is replaced with an arthroplasty. Many different radial head arthroplasties have been designed to replace the bone, and overall, they have enabled patients with complex elbow fractures to regain mobility, stability, and return to sports activities at a level similar to before the fracture. However, some patients experience stiffness, nerve irritation, clicking sounds, or episodes of instability that they consider limiting in their lives. In these cases, it is sometimes necessary to remove the prosthesis if the symptoms are limiting. Currently, although all prosthesis models have demonstrated good performance and achieve good results, the investigators do not know which design is best for each patient and type of fracture. The purpose of this study is to compare two types of radial head arthroplasties commonly used in La Paz Hospital for these fractures, to determine if they achieve similar clinical outcomes after 24 months of follow-up. The investigators want to analyze whether there are differences in satisfaction, range of motion, and functionality in patients operated on with one design or the other, with a stable elbow in both groups. This is a randomized clinical trial, meaning that participants will be assigned to one of the two designs by chance (similar to flipping a coin). The operation will be the same for everyone, only the design of the arthroplasty used will change. One group of patients will receive an anatomic design (Align model from Skeletal Dynamics) and the other group will receive a spacer design (Evolve model from Stryker). Both procedures are performed by experienced surgeons and are safe. Follow-up will include clinical and radiological examinations for at least 24 months after surgery. The clinical follow-up and treatment will be the same whether participants decide to get involved in the study or not, as all procedures correspond to standard clinical practice. Participants' medical care will not depend on participation in this study. If participants decide to participate, it is necessary to sign an Informed Consent form. This study will be conducted at La Paz University Hospital and aims to include approximately 90 patients. The study has been approved by the Research Ethics Committee in La Paz University Hospital in accordance with European Regulation 2017/745 and National Royal Decree 192/2023, which regulates medical devices. Participants may not directly benefit from participating in this study. However, the results may contribute to improved knowledge regarding radial head fractures and arthroplasty in patients who had a complex elbow fracture. Financial Compensation: The participation will not result in any additional cost to participants. No financial compensation will be provided. Contact Information: If participants have any questions regarding the study, the use of medical data, or if participants have concerns or complaints related to the study, the contact will be: Dr. Blanca Diez Sánchez, Dr. Juan Ameztoy Gallego or Dr. Raul Barco Laakso Telephone: +34 91 727 70 00 Ext. 47425

Conditions

Elbow Fracture; Elbow Injury; Elbow Arthropathy; Elbow Dislocation; Elbow Fractures Involving a Combination of Fractures of the Radius and Uln

Keywords

Elbow arthroplasty; Radial head arthroplasty; Spacer design; Anatomic radial head design; Elbow instability

Outcome Measures

Primary Outcomes (1)

• Mayo Elbow Performance Score (MEPS)

  The primary outcome of the study, corresponding to the main objective, will be the Mayo Elbow Performance Score (MEPS) at 24 months of follow-up. This score is measured using a validated, self-administered questionnaire that assesses pain, function, stability, and range of motion of the elbow. The scale ranges from 0 (worst) to 100 (best). The primary endpoint will be assessed as the average MEPS score for each intervention group at 24 months of post-intervention follow-up.

  24 months

Secondary Outcomes (16)

• Range of motion in flexion

  24 months

• Range of motion in extension

  24 months

• Range of motion in pronation

  24 months

• Range of motion in supination

  24 months

• Degree of pain

  24 months

Study Arms (2)

Align radial head arthoplasty (Skeletal Dynamics)

ACTIVE COMPARATOR

press-fit anatomic design

Procedure: Randomized selection of the implant used for surgery

Evolve radial head arthroplasty (Stryker Corporation)

ACTIVE COMPARATOR

smooth-stem spacer

Procedure: Randomized selection of the implant used for surgery

Interventions

Randomized selection of the implant used for surgery PROCEDURE

All patients will be randomly assigned to one radial head replacement or another. Patients will not know the arthoplasty that they have received.

Align radial head arthoplasty (Skeletal Dynamics); Evolve radial head arthroplasty (Stryker Corporation)

Eligibility Criteria

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

You may qualify if:

• Age over 18 years
• Acute, non-reconstructable radial head fracture scheduled for radial head replacement.
• Able to understand the informed consent and patient information sheet and provide written consent.
• Able to and compliant with the planned clinical follow-up: at 6 weeks, 3 months, 6 months, 12 months, and 24 months.
• Underwent acute surgery, excluding treatment for sequelae.
• Radial head replacement using either of the two study designs.

You may not qualify if:

• Previous elbow surgeries or ligamentous or bone injuries managed conservatively.
• Medical contraindications for surgery.
• Medical comorbidities that may interfere with rehabilitation or participation in the study: advanced osteoarthritis, associated chondral lesions, advanced rheumatoid arthritis, neuromuscular or neurovascular disorders, chronic infections or immunodeficiencies, advanced cardiovascular, renal, or pulmonary disease, concurrent or past cancer
• Allergy or contraindication to the use of prosthesis materials.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (19)

• Viveen J, Kodde IF, Heijink A, Koenraadt KLM, van den Bekerom MPJ, Eygendaal D. Why does radial head arthroplasty fail today? A systematic review of recent literature. EFORT Open Rev. 2020 Jan 28;4(12):659-667. doi: 10.1302/2058-5241.4.180099. eCollection 2019 Dec.

  PMID: 32010454 BACKGROUND

• Sun H, Duan J, Li F. Comparison between radial head arthroplasty and open reduction and internal fixation in patients with radial head fractures (modified Mason type III and IV): a meta-analysis. Eur J Orthop Surg Traumatol. 2016 Apr;26(3):283-91. doi: 10.1007/s00590-016-1739-1. Epub 2016 Jan 21.

  PMID: 26794323 BACKGROUND

• Ring D, Psychoyios VN, Chin KR, Jupiter JB. Nonunion of nonoperatively treated fractures of the radial head. Clin Orthop Relat Res. 2002 May;(398):235-8. doi: 10.1097/00003086-200205000-00032.

  PMID: 11964655 BACKGROUND

• Pomianowski S, Morrey BF, Neale PG, Park MJ, O'Driscoll SW, An KN. Contribution of monoblock and bipolar radial head prostheses to valgus stability of the elbow. J Bone Joint Surg Am. 2001 Dec;83(12):1829-34. doi: 10.2106/00004623-200112000-00010.

  PMID: 11741062 BACKGROUND

• Diez Sanchez B, Palacios-Diaz L, Antuna SA, Barco R. Predictors for outlier results after radial head replacement for acute complex elbow instability. J Shoulder Elbow Surg. 2025 Dec 6:S1058-2746(25)00808-0. doi: 10.1016/j.jse.2025.10.020. Online ahead of print.

  PMID: 41360197 BACKGROUND

• Diez Sanchez B, Barco R, Antuna SA. Radial head replacement for acute complex elbow instability: a long-term comparative cohort study of 2 implant designs. J Shoulder Elbow Surg. 2023 Dec;32(12):2581-2589. doi: 10.1016/j.jse.2023.07.023. Epub 2023 Aug 22.

  PMID: 37619928 BACKGROUND

• Ameztoy Gallego J, Diez Sanchez B, Vaquero-Picado A, Antuna S, Barco R. Failed radial head arthroplasty treated by removal of the implant. Bone Joint J. 2024 Nov 1;106-B(11):1327-1332. doi: 10.1302/0301-620X.106B11.BJJ-2024-0330.R1.

  PMID: 39481443 BACKGROUND

• Laflamme M, Grenier-Gauthier PP, Leclerc A, Antoniades S, Bedard AM. Retrospective cohort study on radial head replacements comparing results between smooth and porous stem designs. J Shoulder Elbow Surg. 2017 Aug;26(8):1316-1324. doi: 10.1016/j.jse.2017.04.008. Epub 2017 Jun 9.

  PMID: 28606638 BACKGROUND

• Kodde IF, Viveen J, The B, van Riet RP, Eygendaal D. Management of the failed radial head arthroplasty. EFORT Open Rev. 2020 Aug 1;5(7):398-407. doi: 10.1302/2058-5241.5.190055. eCollection 2020 Jul.

  PMID: 32818067 BACKGROUND

• King GJ, Patterson SD. Metallic radial head arthroplasty. Tech Hand Up Extrem Surg. 2001 Dec;5(4):196-203. doi: 10.1097/00130911-200112000-00003. No abstract available.

  PMID: 16520582 BACKGROUND

• Jensen SL, Olsen BS, Sojbjerg JO. Elbow joint kinematics after excision of the radial head. J Shoulder Elbow Surg. 1999 May-Jun;8(3):238-41. doi: 10.1016/s1058-2746(99)90135-0.

  PMID: 10389079 BACKGROUND

• Jackson JD, Steinmann SP. Radial head fractures. Hand Clin. 2007 May;23(2):185-93, vi. doi: 10.1016/j.hcl.2007.01.009.

  PMID: 17548010 BACKGROUND

• Heifner JJ, Lacau GE, Forro SD, Davis TA, Mercer DM, Rubio F. The impact of anatomic alignment on radiocapitellar pressure following radial head arthroplasty. J Shoulder Elbow Surg. 2024 Sep;33(9):2033-2038. doi: 10.1016/j.jse.2024.02.042. Epub 2024 Apr 10.

  PMID: 38609004 BACKGROUND

• Flinkkila T, Kaisto T, Sirnio K, Hyvonen P, Leppilahti J. Short- to mid-term results of metallic press-fit radial head arthroplasty in unstable injuries of the elbow. J Bone Joint Surg Br. 2012 Jun;94(6):805-10. doi: 10.1302/0301-620X.94B6.28176.

  PMID: 22628596 BACKGROUND

• Doornberg JN, Parisien R, van Duijn PJ, Ring D. Radial head arthroplasty with a modular metal spacer to treat acute traumatic elbow instability. J Bone Joint Surg Am. 2007 May;89(5):1075-80. doi: 10.2106/JBJS.E.01340.

  PMID: 17473146 BACKGROUND

• Davey MS, Davey MG, Hurley ET, Galbraith JG, Molony D, Mullett H, Pauzenberger L. Long-term outcomes of radial head arthroplasty for radial head fractures-a systematic review at minimum 8-year follow-up. J Shoulder Elbow Surg. 2021 Oct;30(10):2438-2444. doi: 10.1016/j.jse.2021.03.142. Epub 2021 Apr 1.

  PMID: 33812024 BACKGROUND

• Beingessner DM, Dunning CE, Gordon KD, Johnson JA, King GJ. The effect of radial head excision and arthroplasty on elbow kinematics and stability. J Bone Joint Surg Am. 2004 Aug;86(8):1730-9. doi: 10.2106/00004623-200408000-00018.

  PMID: 15292422 BACKGROUND

• Antuna SA, Sanchez-Marquez JM, Barco R. Long-term results of radial head resection following isolated radial head fractures in patients younger than forty years old. J Bone Joint Surg Am. 2010 Mar;92(3):558-66. doi: 10.2106/JBJS.I.00332.

  PMID: 20194313 BACKGROUND

• Acevedo DC, Paxton ES, Kukelyansky I, Abboud J, Ramsey M. Radial head arthroplasty: state of the art. J Am Acad Orthop Surg. 2014 Oct;22(10):633-42. doi: 10.5435/JAAOS-22-10-633.

  PMID: 25281258 BACKGROUND

MeSH Terms

Conditions

Elbow Fractures; Elbow Injuries

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Raúl Barco, MD, PhD, FEBOT

  Hospital Universitario La Paz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: May 1, 2026
• Study Start: April 4, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)