Joint DiseaseNCT03113591
Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty
A study testing Minimum invasive total hip arthroplasty and Common total hip arthroplasty in people with Joint Disease, run by Suzhou MicroPort OrthoRecon Co. LTD at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Joint Disease
- What is being tested?
- Minimum invasive total hip arthroplasty and Common total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 29 Aug 2016to 3 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: 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.
- Conditions
- Joint Disease
- Being tested
- Minimum invasive total hip arthroplasty, Common total hip arthroplasty
- Keywords
- total hip arthroplasty, minimal invasive
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimum invasive total hip arthroplastyProcedure or surgery
Minimum invasive total hip arthroplasty using the osteo introducer system
Common total hip arthroplastyProcedure or surgery
Common total hip arthroplasty using common instruments
| Study group | Role | What they receive |
|---|---|---|
| Osteo introducer group | Experimental | undergo minimal invasive total hip arthroplasty surgery Receives: Procedure: Minimum invasive total hip arthroplasty |
| Control group | Active comparator | undergo common total hip arthroplasty surgery Receives: Procedure: Common total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the restoration of hip function at 3 month
Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative
Measured: 3 month
Secondary outcomes (9)
Evaluation of X-ray
Assessment of position, confirm whether there is loosening, dislocation or fracture etc.
Measured: 1day, 6 week, 6 month
Evaluation the restoration of hip function at each time frame
Assessment the Harris Hip Score at each time frame
Measured: 6 week, 3 month, 6 month
Barthel Index
Assessment the daily living activity
Measured: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Berg Balance Scale
Assessment the balance ability
Measured: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Visual Analogue Scale
Assessment the degree of pain
Measured: 1day, 3day, 2 week
The use of analgesics
Investigate the name and dosage of analgesics to indirectly assess the degree of pain
Measured: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Adverse events
Investigate all the adverse events happened during the study period
Measured: 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
Measured: 3 day, 6 week
Dislocation rate
Compare the dislocation rate
Measured: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start29 Aug 2016
- Primary completion13 Sep 2018
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou MicroPort OrthoRecon Co. LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113591
- Sponsor's protocol ID
- MP-GJ15-01
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty: A Prospective, Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03113591
- Acronym / sponsor ID
- MP-GJ15-01
- Conditions
- Joint Disease
- Keywords
- total hip arthroplasty, minimal invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suzhou MicroPort OrthoRecon Co. LTDUniversity, hospital or other
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteo introducer group | Experimental | Procedure: Minimum invasive total hip arthroplastyundergo minimal invasive total hip arthroplasty surgery |
| Control group | Active comparator | Procedure: Common total hip arthroplastyundergo common total hip arthroplasty surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimum invasive total hip arthroplastyMinimum invasive total hip arthroplasty using the osteo introducer system | Procedure or surgery | Osteo introducer group |
| Common total hip arthroplastyCommon total hip arthroplasty using common instruments | Procedure or surgery | Control group |
Primary outcome
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
9 secondary outcomes
Evaluation of X-ray
Time frame: 1day, 6 week, 6 month
Evaluation the restoration of hip function at each time frame
Time frame: 6 week, 3 month, 6 month
Barthel Index
Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Berg Balance Scale
Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Visual Analogue Scale
Time frame: 1day, 3day, 2 week
The use of analgesics
Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Adverse events
Time frame: up to 6 month
Laboratory Examinations
Time frame: 3 day, 6 week
Dislocation rate
Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimum invasive total hip arthroplasty and Common total hip arthroplasty in people with Joint Disease, run by Suzhou MicroPort OrthoRecon Co. LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the restoration of hip function at 3 month (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.