Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

Joint Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113591
• Other study ID #: MP-GJ15-01
• Status: Completed
• Phase: N/A
• Start date: August 29, 2016
• Est. completion date: January 3, 2019

Study information

• Verified date: April 2019
• Source: Suzhou MicroPort OrthoRecon Co. LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 3, 2019
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Intervention

Procedure:
• Minimum invasive total hip arthroplasty
Minimum invasive total hip arthroplasty using the osteo introducer system
• Common total hip arthroplasty
Common total hip arthroplasty using common instruments

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou MicroPort OrthoRecon Co. LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of X-ray	Assessment of position, confirm whether there is loosening, dislocation or fracture etc.	1day, 6 week, 6 month
Secondary	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
Secondary	Barthel Index	Assessment the daily living activity	1day, 3day, 2 week, 6 week, 3 month, 6 month
Secondary	Berg Balance Scale	Assessment the balance ability	1day, 3day, 2 week, 6 week, 3 month, 6 month
Secondary	Visual Analogue Scale	Assessment the degree of pain	1day, 3day, 2 week
Secondary	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
Secondary	Adverse events	Investigate all the adverse events happened during the study period	up to 6 month
Secondary	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
Secondary	Dislocation rate	Compare the dislocation rate	1day, 3day, 2 week, 6 week, 3 month, 6 month