Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty: A Prospective, Multicenter, Randomized Controlled Study

Osteo introducer system is the instruments used in minimal invasive THA. This study will compare the minimal invasive THA using the osteo introducer system and THA using common instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of THA surgery.

Study Overview

• Status: Completed
• Conditions: Joint Disease
• Intervention / Treatment: Procedure: Minimum invasive total hip arthroplasty; Procedure: Common total hip arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Shanghai Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• With indications of total hip arthroplasty (e.g. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis; rheumatoid arthritis; correction of functional deformity, etc.)
• BMI<30
• Subject is a candidate for primary total hip arthroplasty
• No obvious congenital abnormality in hip joint
• Subject has no mental illness, is willing to join the study voluntarily and sign the approved informed consent document; is willing and able to complete required study visits or assessments

Exclusion Criteria:

• Subjects with inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
• Overt infection
• Distant foci of infections
• Allergy to metals
• Rapid disease progression as manifested by joint destruction or bone absorption apparent on X-ray
• Skeletally immature
• Neuropathic joints
• Hepatitis or HIV infection
• Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
• Pregnant or lactating women
• Subjects enrolled in another drug or device clinical investigation within 3 month
• Investigator has judged the subject is not suitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteo introducer group; undergo minimal invasive total hip arthroplasty surgery	Procedure: Minimum invasive total hip arthroplasty; Minimum invasive total hip arthroplasty using the osteo introducer system
Active Comparator: Control group; undergo common total hip arthroplasty surgery	Procedure: Common total hip arthroplasty; Common total hip arthroplasty using common instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation the restoration of hip function at 3 month	Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of X-ray	Assessment of position, confirm whether there is loosening, dislocation or fracture etc.	1day, 6 week, 6 month
Evaluation the restoration of hip function at each time frame	Assessment the Harris Hip Score at each time frame	6 week, 3 month, 6 month
Barthel Index	Assessment the daily living activity	1day, 3day, 2 week, 6 week, 3 month, 6 month
Berg Balance Scale	Assessment the balance ability	1day, 3day, 2 week, 6 week, 3 month, 6 month
Visual Analogue Scale	Assessment the degree of pain	1day, 3day, 2 week
The use of analgesics	Investigate the name and dosage of analgesics to indirectly assess the degree of pain	1day, 3day, 2 week, 6 week, 3 month, 6 month
Adverse events	Investigate all the adverse events happened during the study period	up to 6 month
Laboratory Examinations	Collect the following laboratory results which reflect the traumatic stress:Glu, CRP, Alb, CK, TBA, UA, Ca, Mg, WBC, GRA	3 day, 6 week
Dislocation rate	Compare the dislocation rate	1day, 3day, 2 week, 6 week, 3 month, 6 month

Collaborators and Investigators

• Sponsor: Suzhou MicroPort OrthoRecon Co. LTD

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2016
• Primary Completion (Actual): September 13, 2018
• Study Completion (Actual): January 3, 2019

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 8, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: total hip arthroplasty; minimal invasive
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: MP-GJ15-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No