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Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113591
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Suzhou MicroPort OrthoRecon Co. LTD

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.

Condition or disease Intervention/treatment Phase
Joint Disease Procedure: Minimum invasive total hip arthroplasty Procedure: Common total hip arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty: A Prospective, Multicenter, Randomized Controlled Study
Actual Study Start Date : August 29, 2016
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : January 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

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




Primary Outcome Measures :
  1. Evaluation the restoration of hip function at 3 month [ Time Frame: 3 month ]
    Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative


Secondary Outcome Measures :
  1. Evaluation of X-ray [ Time Frame: 1day, 6 week, 6 month ]
    Assessment of position, confirm whether there is loosening, dislocation or fracture etc.

  2. Evaluation the restoration of hip function at each time frame [ Time Frame: 6 week, 3 month, 6 month ]
    Assessment the Harris Hip Score at each time frame

  3. Barthel Index [ Time Frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month ]
    Assessment the daily living activity

  4. Berg Balance Scale [ Time Frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month ]
    Assessment the balance ability

  5. Visual Analogue Scale [ Time Frame: 1day, 3day, 2 week ]
    Assessment the degree of pain

  6. The use of analgesics [ Time Frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month ]
    Investigate the name and dosage of analgesics to indirectly assess the degree of pain

  7. Adverse events [ Time Frame: up to 6 month ]
    Investigate all the adverse events happened during the study period

  8. Laboratory Examinations [ Time Frame: 3 day, 6 week ]
    Collect the following laboratory results which reflect the traumatic stress:Glu, CRP, Alb, CK, TBA, UA, Ca, Mg, WBC, GRA

  9. Dislocation rate [ Time Frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month ]
    Compare the dislocation rate



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113591


Locations
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China, Shanghai
Shanghai Sixth People's Hospital
Shanghai, Shanghai, China, 200233
Sponsors and Collaborators
Suzhou MicroPort OrthoRecon Co. LTD

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Responsible Party: Suzhou MicroPort OrthoRecon Co. LTD
ClinicalTrials.gov Identifier: NCT03113591     History of Changes
Other Study ID Numbers: MP-GJ15-01
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suzhou MicroPort OrthoRecon Co. LTD:
total hip arthroplasty
minimal invasive
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases