Osteoarthritis, HipNCT03657953
Outcomes 8 Years After Minimal Invasive THA
A study testing surgical approach in people with Osteoarthritis, Hip, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
There exists only limited scientific evidence concerning medium- to long-term benefits concerning minimally invasive (MI) total hip arthroplasty (THA). The investigators examined in a randomized study design 157 patients 8 years after THA, which were performed via 3 different surgical approaches. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- surgical approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2006to 30 Sep 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical and radiologic signs of advanced hip joint Degeneration
- Patients from age 18 to 75
Who cannot join
- osteoporosis and
- osteomalacia,
- preceding surgery or radiation therapy in the proximity of the affected hip joint,
- progressive neoplasia,
- preceding or manifest infection of the affected joint and its surrounding soft tissues,
- rheumatoid arthritis,
Show all 10Show fewer
- hip dysplasia Hartofilakidis type 2 or 3,
- non-compliance,
- chronic neurological or psychiatric diseases,
- ongoing pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Dresden, Orthopaedic Department
Dresden, 01307
About this study
Official title: Patient-relevant Outcomes 8 Years After Minimally Invasive Total Hip Replacement - a Randomized Prospective Study
There exists only limited scientific evidence concerning medium- to long-term benefits concerning minimally invasive (MI) total hip arthroplasty (THA). The investigators examined in a randomized study design 157 patients 8 years after THA, which were performed via 3 different surgical approaches.
Read the detailed description
In contrast to reported short-term advantages of minimally invasive (MI) total hip arthroplasty (THA) there exists only limited scientific evidence concerning medium- to long-term benefits.
The investigators therefore sought to answer the following questions: Is the functional medium-term outcome in THA patients with MI-anterior(MI-A) and MI-anterolateral (MI-AL) approach superior to those treated by direct lateral approach (DLA)? Is the level of life quality increased by MI-THA? Is patient satisfaction higher by MI-THA? Is the revision rate reduced by MI-THA?
- Conditions
- Osteoarthritis, Hip
- Being tested
- surgical approach
- Keywords
- Total Hip Arthroplasty, minimally invasive, Patient-relevant outcomes
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical approachOther
| Study group | Role | What they receive |
|---|---|---|
| anterior (MI-A) surgical approach | Active comparator | The minimally invasive anterior surgical approach was carried out using a modified Smith-Petersen access as described by Bender et al. (Bender et al. 2009) with the patient in supine position. Receives: Other: surgical approach |
| anterolateral (MI-AL) surgical approach | Active comparator | For the minimally invasive anterolateral surgical approach, a modified Watson-Jones approach according to Röttinger (Rottinger et al. 2006) was applied with the patient in supine position. Receives: Other: surgical approach |
| direct lateral (DLA) surgical approach | Active comparator | The direct lateral surgical approach was performed according to the technique described by Hardinge et al. (Hardinge et al. 1982) with the patient positioned supine Receives: Other: surgical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function hip - Harris-Hip-Score (HHS)
Harris-Hip-Score (worst=0, best=100)
Measured: change from baseline (preoperative) at 8 years after THA
Secondary outcomes (8)
Physical function hip - WOMAC
WOMAC Total Score (worst=0, best=100)
Measured: change from baseline (preoperative) at 8 years after THA
Satisfaction Level
Satisfaction scale (worst=0, best=10)
Measured: at 8 years after THA
health related Quality of life - Index
EuroQol in 5 dimensions (EQ-5D) Index (worst=0, best=1)
Measured: change from baseline (preoperative) at 8 years after THA
health related Quality of life - VAS
EQ-Visual Analogue Scale (worst=0, best=100)
Measured: change from baseline (preoperative) at 8 years after THA
Physical Activity
University of California, Los Angeles (UCLA) Activity Scale (worst=1, best=10)
Measured: change from baseline (preoperative) at 8 years after THA
Revision rate
Revision rate using Kaplan-Meier-Survival Analysis
Measured: at 8 years after THA
Physical Activity Performance Test: walking
25-meter walking time
Measured: change from baseline (preoperative) at 8 years after THA
Physical Activity Performance Test: stair climbing
5-step walking time
Measured: change from baseline (preoperative) at 8 years after THA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Jan 2006
- Primary completion30 Jun 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Model description
- single-center prospective randomized study design
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments
- Responsible party
- Sponsor
- Investigators
- Maik Stiehler, MD, Principal investigator, University Center for Orthopaedics and Trauma Surgery, University Hospital Carl Gustav
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657953
- Sponsor's protocol ID
- THA MIC
- Status last verified
- Sep 2018
- First submitted
- 14 Aug 2018
- Last updated
- 5 Sep 2018
- 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 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-relevant Outcomes 8 Years After Minimally Invasive Total Hip Replacement - a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03657953
- Acronym / sponsor ID
- THA MIC
- Conditions
- Osteoarthritis, Hip
- Keywords
- Total Hip Arthroplasty, minimally invasive, Patient-relevant outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Stryker Instruments
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 5 Sep 2018 (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.
There exists only limited scientific evidence concerning medium- to long-term benefits concerning minimally invasive (MI) total hip arthroplasty (THA). The investigators examined in a randomized study design 157 patients 8 years after THA, which were performed via 3 different surgical approaches.
Detailed description
In contrast to reported short-term advantages of minimally invasive (MI) total hip arthroplasty (THA) there exists only limited scientific evidence concerning medium- to long-term benefits.
The investigators therefore sought to answer the following questions: Is the functional medium-term outcome in THA patients with MI-anterior(MI-A) and MI-anterolateral (MI-AL) approach superior to those treated by direct lateral approach (DLA)? Is the level of life quality increased by MI-THA? Is patient satisfaction higher by MI-THA? Is the revision rate reduced by MI-THA?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- single-center prospective randomized study design
| Arm | Type | Receives |
|---|---|---|
| anterior (MI-A) surgical approach | Active comparator | Other: surgical approachThe minimally invasive anterior surgical approach was carried out using a modified Smith-Petersen access as described by Bender et al. (Bender et al. 2009) with the patient in supine position. |
| anterolateral (MI-AL) surgical approach | Active comparator | Other: surgical approachFor the minimally invasive anterolateral surgical approach, a modified Watson-Jones approach according to Röttinger (Rottinger et al. 2006) was applied with the patient in supine position. |
| direct lateral (DLA) surgical approach | Active comparator | Other: surgical approachThe direct lateral surgical approach was performed according to the technique described by Hardinge et al. (Hardinge et al. 1982) with the patient positioned supine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical and radiologic signs of advanced hip joint Degeneration
- Patients from age 18 to 75
Key exclusion criteria (10 listed)
- osteoporosis and
- osteomalacia,
- preceding surgery or radiation therapy in the proximity of the affected hip joint,
- progressive neoplasia,
- preceding or manifest infection of the affected joint and its surrounding soft tissues,
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 |
|---|---|---|
| surgical approach | Other | anterior (MI-A) surgical approach, anterolateral (MI-AL) surgical approach, direct lateral (DLA) surgical approach |
Primary outcome
Physical function hip - Harris-Hip-Score (HHS)
Time frame: change from baseline (preoperative) at 8 years after THA
Harris-Hip-Score (worst=0, best=100)
8 secondary outcomes
Physical function hip - WOMAC
Time frame: change from baseline (preoperative) at 8 years after THA
Satisfaction Level
Time frame: at 8 years after THA
health related Quality of life - Index
Time frame: change from baseline (preoperative) at 8 years after THA
health related Quality of life - VAS
Time frame: change from baseline (preoperative) at 8 years after THA
Physical Activity
Time frame: change from baseline (preoperative) at 8 years after THA
Revision rate
Time frame: at 8 years after THA
Physical Activity Performance Test: walking
Time frame: change from baseline (preoperative) at 8 years after THA
Physical Activity Performance Test: stair climbing
Time frame: change from baseline (preoperative) at 8 years after THA
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 5 Sep 2018.
- 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.
Maik Stiehler, MD principal investigator
University Center for Orthopaedics and Trauma Surgery, University Hospital Carl Gustav
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical approach in people with Osteoarthritis, Hip, run by Technische Universität Dresden at 1 site in Germany.
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 2 inclusion and 10 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 5 Sep 2018. 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 Germany. 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?
Physical function hip - Harris-Hip-Score (HHS) (time frame: change from baseline (preoperative) at 8 years after THA). 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 5 Sep 2018.