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

Arthritis, Failure of Total Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02208271
• Other study ID #: HK003-14014
• Status: Suspended
• Start date: August 4, 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Well-functioning MoM implants have shown an increase in serum cobalt and chromium (CoCr) ion levels from the metal debris generated from the implant wear.However, the current evidence suggests that measuring ion levels is unreliable and that increasing ion levels do not correlate with tissue damage. In addition to measuring blood and synovial fluid metal ion levels, ultrasound and MRI with metal artifact reduction sequences (MARS) have been utilized to assess periarticular reactions secondary to metal wear debris. Despite metal reduction software these scans are frequently difficult to interpret. While each of these tests has merit, at the present time there is no single diagnostic test available which delineates the key issue that demands urgent surgical intervention, i.e. tissue necrosis. It is important to have a reliable test to guide surgeons and patients in the shared decision-making process of when surgical intervention is necessary to prevent disabling tissue damage. For this reason, the current study proposes an examination of preoperative serum samples of subjects in addition to synovial fluid collected during revision surgery for biomarkers that may indicate tissue necrosis. To maximize the chance of success of identifying serum biomarkers, all samples will be analyzed using multianalyte assay, biomarker tests. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 174
• Est. completion date: December 31, 2024
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthritis, Failure of Total Hip
• Necrosis

Locations

Country	Name	City	State
United States	OrthoCarolina	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.	Charlotte Orthopedic Hospital

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of patients with tissue necrosis	Tissue necrosis will be assessed during total hip surgery.; Tissue necrosis will be scored in subsets including: intraoperative tissue damage, histological necrosis score, histologic ALVAL score, inflammatory infiltrate, and tissue organization	participants will be followed for the duration of their hospital stay, an expected average of 2 hours