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Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

Primary Purpose

Joint Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Minimum invasive total hip arthroplasty
Common total hip arthroplasty
Sponsored by
Suzhou MicroPort OrthoRecon Co. LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Disease focused on measuring total hip arthroplasty, minimal invasive

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Sixth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osteo introducer group

Control group

Arm Description

undergo minimal invasive total hip arthroplasty surgery

undergo common total hip arthroplasty surgery

Outcomes

Primary Outcome Measures

Evaluation the restoration of hip function at 3 month
Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2017
Last Updated
April 2, 2019
Sponsor
Suzhou MicroPort OrthoRecon Co. LTD
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1. Study Identification

Unique Protocol Identification Number
NCT03113591
Brief Title
Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty
Official Title
Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty: A Prospective, Multicenter, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
September 13, 2018 (Actual)
Study Completion Date
January 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou MicroPort OrthoRecon Co. LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease
Keywords
total hip arthroplasty, minimal invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteo introducer group
Arm Type
Experimental
Arm Description
undergo minimal invasive total hip arthroplasty surgery
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
undergo common total hip arthroplasty surgery
Intervention Type
Procedure
Intervention Name(s)
Minimum invasive total hip arthroplasty
Intervention Description
Minimum invasive total hip arthroplasty using the osteo introducer system
Intervention Type
Procedure
Intervention Name(s)
Common total hip arthroplasty
Intervention Description
Common total hip arthroplasty using common instruments
Primary Outcome Measure Information:
Title
Evaluation the restoration of hip function at 3 month
Description
Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Evaluation of X-ray
Description
Assessment of position, confirm whether there is loosening, dislocation or fracture etc.
Time Frame
1day, 6 week, 6 month
Title
Evaluation the restoration of hip function at each time frame
Description
Assessment the Harris Hip Score at each time frame
Time Frame
6 week, 3 month, 6 month
Title
Barthel Index
Description
Assessment the daily living activity
Time Frame
1day, 3day, 2 week, 6 week, 3 month, 6 month
Title
Berg Balance Scale
Description
Assessment the balance ability
Time Frame
1day, 3day, 2 week, 6 week, 3 month, 6 month
Title
Visual Analogue Scale
Description
Assessment the degree of pain
Time Frame
1day, 3day, 2 week
Title
The use of analgesics
Description
Investigate the name and dosage of analgesics to indirectly assess the degree of pain
Time Frame
1day, 3day, 2 week, 6 week, 3 month, 6 month
Title
Adverse events
Description
Investigate all the adverse events happened during the study period
Time Frame
up to 6 month
Title
Laboratory Examinations
Description
Collect the following laboratory results which reflect the traumatic stress:Glu, CRP, Alb, CK, TBA, UA, Ca, Mg, WBC, GRA
Time Frame
3 day, 6 week
Title
Dislocation rate
Description
Compare the dislocation rate
Time Frame
1day, 3day, 2 week, 6 week, 3 month, 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

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