Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

NCT03113591 | Completed

• 1 other identifier: MP-GJ15-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Joint Disease

Keywords

total hip arthroplasty; minimal invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Evaluation of X-ray

  1day, 6 week, 6 month

• Evaluation the restoration of hip function at each time frame

  6 week, 3 month, 6 month

• Barthel Index

  1day, 3day, 2 week, 6 week, 3 month, 6 month

• Berg Balance Scale

  1day, 3day, 2 week, 6 week, 3 month, 6 month

• Visual Analogue Scale

  1day, 3day, 2 week

Study Arms (2)

Osteo introducer group

EXPERIMENTAL

undergo minimal invasive total hip arthroplasty surgery

Procedure: Minimum invasive total hip arthroplasty

Control group

ACTIVE COMPARATOR

undergo common total hip arthroplasty surgery

Procedure: Common total hip arthroplasty

Interventions

Minimum invasive total hip arthroplasty PROCEDURE

Minimum invasive total hip arthroplasty using the osteo introducer system

Osteo introducer group

Common total hip arthroplasty PROCEDURE

Common total hip arthroplasty using common instruments

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou MicroPort OrthoRecon Co. LTD: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 13, 2017
• Study Start: August 29, 2016
• Primary Completion: September 13, 2018
• Study Completion: January 3, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)