Arthroplasty, Replacement, HipNCT01031732
Evaluation of Four Surgical Techniques in Primary Total Hip Arthroplasty
A study testing MIS-2 THA, MIS-WJ and MIS-AL THA in people with Arthroplasty, Replacement, Hip, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Current "Minimally Invasive THR" includes: (1) Minimally Invasive Two-Incision THR (MIS-2), (2) Minimally Invasive Modified Watson-Jones THR (MIS-WJ). In contrast, "mini-incision" utilizes smaller incision (< 10 cm in definition) to perform the THR which can further be divided into mini-anterolateral (Mini-AL) and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- MIS-2 THA, MIS-WJ and MIS-AL THA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2009to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unilateral hip disease that is indicated for primary total hip arthroplasty.
Who cannot join
- A previous THA on the contralateral hip.
- Any condition contraindicated for primary total hip arthroplasty.
- Refuse to be randomized in the study arms.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Kweishan, Taoyuan, 333
Mel S Lee, MD, PhD, 886-968372599, mellee@adm.cgmh.org.tw
Mel S Lee, MD, PhD
About this study
Official title: A Prospective Randomized Controlled 4-arm Study for the Evaluation of 4 Surgical Techniques in Primary Total Hip Arthroplasty
Current "Minimally Invasive THR" includes: (1) Minimally Invasive Two-Incision THR (MIS-2), (2) Minimally Invasive Modified Watson-Jones THR (MIS-WJ). In contrast, "mini-incision" utilizes smaller incision (< 10 cm in definition) to perform the THR which can further be divided into mini-anterolateral (Mini-AL) and mini-posterolateral (Mini-PL).The purpose of this study is to investigate how MIS THR can affect the results of THR by a prospective randomized clinical trial. It is hoped that some new standards could be established for the total hip replacement surgery.
Read the detailed description
The prospective randomized study will be performed in patients after obtaining patient's consent. "Envelop drawing based on random table" will decide the choice of approach. (1) Group 1: MIS-2, 30 cases (2) Group 2: MIS-WJ, 30 cases (3) Group 3: Mini-AL, 30 cases (4) Group 4: Mini-PL, 30 cases. Only the unilateral coxarthrosis will be recruited for the study. Analytical methods include (1) gait analysis (2) cybex study (3) balance test and obstacle crossing test (4) bone densitometry (5) PETS oxygen consumption and glucose utilization tests (6) inflammatory markers (7) clinical assessment (8) X-ray studies. Patients will be scheduled for specified examinations preoperatively, postoperatively and within 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, and 36 months.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- MIS-2 THA, MIS-WJ, MIS-AL THA, MIS-PL THA
- Keywords
- Minimally invasive, Total hip arthroplasty, Functional outcome, To compare the surgical results of 4 MIS THA techniques, To investigate the functional outcomes of 4 MIS THA techniques, To study the biochemical parameters after the MIS surgeries.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIS-2 THAProcedure or surgery
MIS two-incision THA
MIS-WJProcedure or surgery
MIS-Watson Jones THA
MIS-AL THAProcedure or surgery
Transgluteal approach
MIS-PL THAProcedure or surgery
Posterolateral approach
| Study group | Role | What they receive |
|---|---|---|
| Two-incision | Experimental | MIS-2 THA Receives: Procedure: MIS-2 THA |
| Watson-Jones | Experimental | MIS-WJ Receives: Procedure: MIS-WJ |
| MIS-AL | Experimental | Not described Receives: Procedure: MIS-AL THA |
| MIS-PL | Experimental | Not described Receives: Procedure: MIS-PL THA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and Harris hip score
Measured: 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary outcomes (1)
Functional outcomes assessment
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031732
- Sponsor's protocol ID
- 97-2177c
- Status last verified
- May 2010
- First submitted
- 13 Dec 2009
- Last updated
- 31 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chou SW, Ueng SW, Lee MS. Muscular recovery of hip flexors and extensors after two-incision total hip arthroplasty. Chang Gung Med J. 2008 Nov-Dec;31(6):576-82.
PubMed 19241897Chen DW, Hu CC, Chang YH, Yang WE, Lee MS. Comparison of clinical outcome in primary total hip arthroplasty by conventional anterolateral transgluteal or 2-incision approach. J Arthroplasty. 2009 Jun;24(4):528-32. doi: 10.1016/j.arth.2008.03.016. Epub 2008 Aug 3.
PubMed 18676112Hu CC, Yang WE, Chang YH, Chen DW, Ueng SW, Lee MS. Fluoroscopy cannot recognize intraoperative fracture in patients receiving 2-incision total hip arthroplasty. J Arthroplasty. 2008 Oct;23(7):1031-6. doi: 10.1016/j.arth.2007.09.026. Epub 2008 Mar 4.
PubMed 18534477Lu ML, Chou SW, Yang WE, Senan V, Hsieh PH, Shih HN, Lee MS. Hospital course and early clinical outcomes of two-incision total hip arthroplasty. Chang Gung Med J. 2007 Nov-Dec;30(6):513-20.
PubMed 18350734Lee MS, Kuo CH, Senan V, Chen WJ, Chen LH, Ueng SW. Two-incision total hip replacement: Intra-operative fluoroscopy versus imageless navigation for cup placement. Hip Int. 2006;16 Suppl 4:35-41. doi: 10.1177/112070000601604S08.
PubMed 19219827
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled 4-arm Study for the Evaluation of 4 Surgical Techniques in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01031732
- Acronym / sponsor ID
- 97-2177c
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Minimally invasive, Total hip arthroplasty, Functional outcome, To compare the surgical results of 4 MIS THA techniques, To investigate the functional outcomes of 4 MIS THA techniques, To study the biochemical parameters after the MIS surgeries.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Dec 2009 (estimated)
- 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.
Current "Minimally Invasive THR" includes: (1) Minimally Invasive Two-Incision THR (MIS-2), (2) Minimally Invasive Modified Watson-Jones THR (MIS-WJ). In contrast, "mini-incision" utilizes smaller incision (< 10 cm in definition) to perform the THR which can further be divided into mini-anterolateral (Mini-AL) and mini-posterolateral (Mini-PL).The purpose of this study is to investigate how MIS THR can affect the results of THR by a prospective randomized clinical trial. It is hoped that some new standards could be established for the total hip replacement surgery.
Detailed description
The prospective randomized study will be performed in patients after obtaining patient's consent. "Envelop drawing based on random table" will decide the choice of approach. (1) Group 1: MIS-2, 30 cases (2) Group 2: MIS-WJ, 30 cases (3) Group 3: Mini-AL, 30 cases (4) Group 4: Mini-PL, 30 cases. Only the unilateral coxarthrosis will be recruited for the study. Analytical methods include (1) gait analysis (2) cybex study (3) balance test and obstacle crossing test (4) bone densitometry (5) PETS oxygen consumption and glucose utilization tests (6) inflammatory markers (7) clinical assessment (8) X-ray studies. Patients will be scheduled for specified examinations preoperatively, postoperatively and within 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, and 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Two-incision | Experimental | Procedure: MIS-2 THAMIS-2 THA |
| Watson-Jones | Experimental | Procedure: MIS-WJMIS-WJ |
| MIS-AL | Experimental | Procedure: MIS-AL THA |
| MIS-PL | Experimental | Procedure: MIS-PL THA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral hip disease that is indicated for primary total hip arthroplasty.
Key exclusion criteria (3 listed)
- A previous THA on the contralateral hip.
- Any condition contraindicated for primary total hip arthroplasty.
- Refuse to be randomized in the study arms.
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 |
|---|---|---|
| MIS-2 THAMIS two-incision THA | Procedure or surgery | Two-incision |
| MIS-WJMIS-Watson Jones THA | Procedure or surgery | Watson-Jones |
| MIS-AL THATransgluteal approach | Procedure or surgery | MIS-AL |
| MIS-PL THAPosterolateral approach | Procedure or surgery | MIS-PL |
Primary outcome
Pain and Harris hip score
Time frame: 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
1 secondary outcome
Functional outcomes assessment
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2010.
- Background: PubMed 19241897Chou SW, Ueng SW, Lee MS. Muscular recovery of hip flexors and extensors after two-incision total hip arthroplasty. Chang Gung Med J. 2008 Nov-Dec;31(6):576-82.
- Background: PubMed 18676112Chen DW, Hu CC, Chang YH, Yang WE, Lee MS. Comparison of clinical outcome in primary total hip arthroplasty by conventional anterolateral transgluteal or 2-incision approach. J Arthroplasty. 2009 Jun;24(4):528-32. doi: 10.1016/j.arth.2008.03.016. Epub 2008 Aug 3.
- Background: PubMed 18534477Hu CC, Yang WE, Chang YH, Chen DW, Ueng SW, Lee MS. Fluoroscopy cannot recognize intraoperative fracture in patients receiving 2-incision total hip arthroplasty. J Arthroplasty. 2008 Oct;23(7):1031-6. doi: 10.1016/j.arth.2007.09.026. Epub 2008 Mar 4.
- Background: PubMed 18350734Lu ML, Chou SW, Yang WE, Senan V, Hsieh PH, Shih HN, Lee MS. Hospital course and early clinical outcomes of two-incision total hip arthroplasty. Chang Gung Med J. 2007 Nov-Dec;30(6):513-20.
- Background: PubMed 19219827Lee MS, Kuo CH, Senan V, Chen WJ, Chen LH, Ueng SW. Two-incision total hip replacement: Intra-operative fluoroscopy versus imageless navigation for cup placement. Hip Int. 2006;16 Suppl 4:35-41. doi: 10.1177/112070000601604S08.
- Chang Gung Memorial HospitalLink provided by the sponsor.
- American Academy of Orthopaedic SurgeonsLink provided by the sponsor.
- Chang Gung UniversityLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIS-2 THA, MIS-WJ and MIS-AL THA in people with Arthroplasty, Replacement, Hip, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 May 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mel S Lee, MD, PhD (886-968372599, mellee@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and Harris hip score (time frame: 5 days, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031732, which also lists 5 linked publications.
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 31 May 2010; AzTrials last refreshed its copy on 7 Nov 2026.