A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty

NCT02208271 | Suspended DMC

• 1 other identifier: HK003-14014
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement. A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant, control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial fluid will be obtained from all hips and used for biomarker testing. Additionally, intraoperative assessment of tissue necrosis will be assessed.

Conditions

Arthritis, Failure of Total Hip

Keywords

tissue necrosis; metal on metal total hip; biomarker

Outcome Measures

Primary Outcomes (1)

• The number of patients with serum and synovial fluid biomarkers

  Blood Serum and Synovial fluid will be tested using a multi-analyte assay test

  participants will be followed for the duration of their hospital stay, an expected average of 2 hours

Secondary Outcomes (1)

• The number of patients with tissue necrosis

  participants will be followed for the duration of their hospital stay, an expected average of 2 hours

Study Arms (3)

Control

pre-operative total hip patients with no existing total hip implant

Metal on polyethylene

patients who have a failed metal on polyethylene total hip implant and are presenting for revision surgery

Metal on Metal

patients who have a failed metal on metal total hip implant and are presenting for revision surgery

Eligibility Criteria

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

Study Population

A convenience sample of a total of 100 hip patients will be enrolled at orthopedic clinics.

You may qualify if:

• Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested within 6 months of the date of the planned revision surgery.
• Patients presenting for a metal on poly hip revision
• Revision hip patients must be greater than one year postoperative
• The diagnosis at the time of the index, or primary, hip replacement was osteoarthritis.
• Patients who have hip osteoarthritis but have not had a total hip surgery (control)

You may not qualify if:

• Patients presenting for a metal on metal hip revision who have cobalt and chromium metal ion levels tested \>6 months of the date of the planned revision
• Patients with a total hip on the contralateral side.
• Patients with a prior history of periprosthetic infection
• Revision cases where the diagnosis at the time of the index, or primary, hip replacement was not osteoarthritis.
• Prisoners
• Patients not willing to consent for the proposed treatment
• Patients with an altered mental status
• Active, concurrent metastatic infection
• Active, superficial infection
• Patients presenting for a metal on poly hip revision to treat trunionosis

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead
• Charlotte Orthopedic Hospital: collaborator

Study Sites (1)

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Related Publications (9)

• MacDonald SJ. Metal-on-metal total hip arthroplasty: the concerns. Clin Orthop Relat Res. 2004 Dec;(429):86-93. doi: 10.1097/01.blo.0000150309.48474.8b.

  PMID: 15577471 BACKGROUND

• Lindgren JU, Brismar BH, Wikstrom AC. Adverse reaction to metal release from a modular metal-on-polyethylene hip prosthesis. J Bone Joint Surg Br. 2011 Oct;93(10):1427-30. doi: 10.1302/0301-620X.93B10.27645.

  PMID: 21969447 BACKGROUND

• Lombardi AV Jr, Barrack RL, Berend KR, Cuckler JM, Jacobs JJ, Mont MA, Schmalzried TP. The Hip Society: algorithmic approach to diagnosis and management of metal-on-metal arthroplasty. J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):14-8. doi: 10.1302/0301-620X.94B11.30680.

  PMID: 23118373 BACKGROUND

• Cobb AG, Schmalzreid TP. The clinical significance of metal ion release from cobalt-chromium metal-on-metal hip joint arthroplasty. Proc Inst Mech Eng H. 2006 Feb;220(2):385-98. doi: 10.1243/09544119JEIM78.

  PMID: 16669404 BACKGROUND

• Mabilleau G, Kwon YM, Pandit H, Murray DW, Sabokbar A. Metal-on-metal hip resurfacing arthroplasty: a review of periprosthetic biological reactions. Acta Orthop. 2008 Dec;79(6):734-47. doi: 10.1080/17453670810016795.

  PMID: 19085489 BACKGROUND

• Tower SS. Arthroprosthetic cobaltism: neurological and cardiac manifestations in two patients with metal-on-metal arthroplasty: a case report. J Bone Joint Surg Am. 2010 Dec 1;92(17):2847-51. doi: 10.2106/JBJS.J.00125. Epub 2010 Oct 29. No abstract available.

  PMID: 21037026 BACKGROUND

• Campbell P, Ebramzadeh E, Nelson S, Takamura K, De Smet K, Amstutz HC. Histological features of pseudotumor-like tissues from metal-on-metal hips. Clin Orthop Relat Res. 2010 Sep;468(9):2321-7. doi: 10.1007/s11999-010-1372-y.

  PMID: 20458645 BACKGROUND

• Leopold SS, Berger RA, Patterson L, Skipor AK, Urban RM, Jacobs JJ. Serum titanium level for diagnosis of a failed, metal-backed patellar component. J Arthroplasty. 2000 Oct;15(7):938-43. doi: 10.1054/arth.2000.6632.

  PMID: 11061457 BACKGROUND

• Griffin WL, Fehring TK, Kudrna JC, Schmidt RH, Christie MJ, Odum SM, Dennos AC. Are metal ion levels a useful trigger for surgical intervention? J Arthroplasty. 2012 Sep;27(8 Suppl):32-6. doi: 10.1016/j.arth.2012.03.020. Epub 2012 May 17.

  PMID: 22608683 BACKGROUND

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Thomas Fehring, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: August 5, 2014
• Study Start: August 4, 2014
• Primary Completion: May 17, 2018
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

US (1)