A Study on M2a Magnum Total Hip Arthroplasty

Avascular Necrosis Clinical Trial

Official title:

A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010763
• Other study ID #: INT.CR.RROW2
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: April 28, 2017

Study information

• Verified date: March 2019
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.

Description:

There are no clinical studies conducted on its performance in Asian population. Furthermore clinical data is required to support marketing and validate design of M2A Magnum.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: April 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients suitable for primary Total Hip Replacement

• Patients aged over 20

• Patients with limited co-morbidity- ASA I-III

• Patients must be able to understand instructions and be willing to return for follow-up

• Patients willing to provide blood and urine samples for metal ion analysis at follow-up

Exclusion Criteria:

• Pre-existing metal implants

• Infection, sepsis, and osteomyelitis

• Uncooperative patient or pt with neurologic disorders who are 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

• vascular insufficiency, muscular atrophy, or neuromuscular disease

• pregnancy

Related Conditions & MeSH terms

• Avascular Necrosis
• Degenerative Joint Disease
• Joint Diseases
• Necrosis
• Osteoarthritis

Intervention

Device:
• Total Hip Arthroplasty
Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital	Amagasaki	Hyogo Pref.

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion	Hip Flexion Angle at 1 year postoperatively	1 year
Secondary	Metal Ion	Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.	3 month
Secondary	UCLA Activity Score	UCLA is physician assessing scoring system to assess patient's activity level. Minimum score is 0 (completely inactive) and maximum score is 9 (Regularly participates in impact sports) with 1 point increments depending on patient's activity level.; Higher score means higher activity level achieved.	5 year
Secondary	Radiographic Assessment	number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)	5 year
Secondary	Harris Hip Score	Harris Hip Score is physician assessing hip functional scoring system, which includes 4 components (pain, function, deformity and range of motion) with minimum score of 0 & maximum score of 100.; Maximum & Minimum score of each subscale is pain: 0-44, function: 0-47, Deformity: 0-4 and Range of motion: 0-5.; Current report uses summed score of each patient to compare total Harris Hip Score.; Higher score means better outcomes.	5 year
Secondary	Metal Ion	Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.	6 month
Secondary	Metal Ion	Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.	1 year
Secondary	Metal Ion	Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.	2 year
Secondary	Metal Ion	Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.	3 year
Secondary	Metal Ion	Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.	4 year
Secondary	Metal Ion	Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.	5 year