Total Hip ArthroplastyNCT04358250
Tissue Sparing Surgery in Total Hip Arthroplasty
A study testing Direct Superior Approach and posterolateral approach in people with Total Hip Arthroplasty and Hip Arthrosis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
Trial summary
Rationale of the study is to evaluate through a prospective randomized controlled study if a modified direct superior posterolateral approach (sperimental approach) to the hip articulation which entirely spares i.e. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Hip Arthroplasty, Hip Arthrosis
- What is being tested?
- Direct Superior Approach and posterolateral approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 26 Apr 2017to 30 Nov 2018
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-inflammatory degenerative joint disease, including osteoarthritis
- Patients in the age from 60 to 85 included
- Consenting to actively participate in the study and in the rehabilitation follow up program as foreseen by the study
- 18 ≤ Body Mass Index (BMI) ≥ 30 kg/m2
- patient without contralateral THA
- Exclusion Criteria:-Revision procedures where other treatments or devices have failed
Show all 11Show fewer
- Active infection or suspected latent infection in or about the hip joint
- Bone stock that is inadequate for support or fixation of the prosthesis
- skeletal immaturity
- any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complication in post-operative care
- Obesity (BMI ≥30kg/m2)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Istituto Ortopedico Galeazzi
Milan, 20161
About this study
Rationale of the study is to evaluate through a prospective randomized controlled study if a modified direct superior posterolateral approach (sperimental approach) to the hip articulation which entirely spares i.e. avoids the sacrifice of the fascia lata might elicit a better outcome in terms of gait, balance, strengths recovery, clinical performance, patient reported outcome measurement (Short Form-12(SF-12); Hip disability and Osteoarthritis Outcome Score (HOOS)) and overall recovery time in patients undergoing TotalHipArthroplasty with the aid of dedicated, modified instrumentation in order to properly access this modified route.
The investigators expect an improvement on selected gait analysis parameters in sperimental approach in order of 2% of range of motion (ROM) recorded 1 month after surgery. Based on this assumption sample size calculation will be conducted.
Read the detailed description
Rationale of the study is to evaluate through a prospective randomized controlled study if a modified direct superior approach (experimental approach) to the hip articulation which entirely spares i.e. avoids the sacrifice of the fascia lata (posterolateral approach) might elicit a better outcome in terms of gait, balance,strenghts recovery, clinical performance, patient reported outcome measurements and overall recovery time in patients undergoing TotalHipArthroplasty with the aid of dedicated, modified instrumentation in order to properly access this modified route.Two patients groups will randomly be allocated in one of the two group with a computer generated 1:1 randomization table.Total number of subjects participating in the study:50.
- Conditions
- Total Hip Arthroplasty, Hip Arthrosis
- Being tested
- Direct Superior Approach, posterolateral approach
- Keywords
- tissue sparing surgery
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Superior ApproachProcedure or surgery
Also called DSA
GROUP II :Patients positioned in lateral decubitus.landmark for incision is the apex of the greater trochanter,and skin, subcutaneous tissue except fascia are incised accordingly. Fibers of gluteus will be separated and not incised.posterior capsulotomy is performed,;femur is dislocated and neck osteotomy carried out, followed by preparation of femoral canal with progressive broach. Acetabulum is prepared with burs of increasing diameter, and acetabular cup is impacted. A polyethylene insert and a femoral rasp are subsequently introduced.All remaining definitive implants can be positioned.
posterolateral approachProcedure or surgery
GROUP I:patients are positioned in lateral decubitus.Landmark for incision is the apex of the greater trochanter.posterior capsulotomy is performed, femur is dislocated and neck osteotomy carried out, followed by preparation of femoral canal with progressive broach.Acetabulum is prepared with burs of increasing diameter,and acetabular cup is then impacted.All definitive implants can be positioned.
| Study group | Role | What they receive |
|---|---|---|
| direct superior approach | Experimental | Direct superior approach 25 patients Receives: Procedure: Direct Superior Approach |
| posterolateral approach | Active comparator | posterolateral approach 25 patients Receives: Procedure: posterolateral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate spatiotemporal variables in meters among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
spatiotemporal variables: step length (meters), stride length (meters).
Measured: Change from Baseline spatiotemporal variables in meters at 3 months
evaluate spatiotemporal variables in percentage among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
Spatiotemporal variables: stance phase (percentage), swing phase (percentage)
Measured: Change from Baseline spatiotemporal variables in percentage at 3 months
evaluate kinematic parameters in degrees among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
Kinematic parameters (in degrees): hip flexion-extension ROM, hip abduction-adduction ROM, Hip rotation ROM, Hip Obliquity ROM.
Measured: Change from Baseline Kinematic parameters in degrees at 3 months
Secondary outcomes (1)
evaluation of instability with BEStest
BESTest (Balance Evaluation System Test) that evaluate the risk of fall . Each patient will be asked to wear a belt and two gloves containing the magnetic sensors and to follow the OAK device instruction.The portable device detects, on real time, the position and the orientation of each sensor. It yields a point-score from 0 to 24 and it has been shown that the relative optimal cut-off point was a 16 point-score out of 24: a point score between 17 and 24 classifies a subject as low risk who would otherwise be classified as being at medium/high risk (the duration will be approximately 10 minutes)
Measured: Change from Baseline BESTest at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start26 Apr 2017
- Primary completion25 Oct 2017
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Ulivi, Principal investigator, IRCCS Istituto Ortopedico GaleazziMilano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358250
- Sponsor's protocol ID
- TSSINTHA2016
- Status last verified
- Apr 2020
- First submitted
- 18 Jan 2018
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ulivi M, Orlandini L, Vitale JA, Meroni V, Prandoni L, Mangiavini L, Rossi N, Peretti GM. Direct superior approach versus posterolateral approach in total hip arthroplasty: a randomized controlled trial on early outcomes on gait, risk of fall, clinical and self-reported measurements. Acta Orthop. 2021 Jun;92(3):274-279. doi: 10.1080/17453674.2020.1865633. Epub 2021 Jan 7.
PubMed 33410360
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Sparing Surgery in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04358250
- Acronym / sponsor ID
- TSSINTHA2016
- Conditions
- Total Hip Arthroplasty, Hip Arthrosis
- Keywords
- tissue sparing surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 24 Apr 2020 (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.
Rationale of the study is to evaluate through a prospective randomized controlled study if a modified direct superior posterolateral approach (sperimental approach) to the hip articulation which entirely spares i.e. avoids the sacrifice of the fascia lata might elicit a better outcome in terms of gait, balance, strengths recovery, clinical performance, patient reported outcome measurement (Short Form-12(SF-12); Hip disability and Osteoarthritis Outcome Score (HOOS)) and overall recovery time in patients undergoing TotalHipArthroplasty with the aid of dedicated, modified instrumentation in order to properly access this modified route.
The investigators expect an improvement on selected gait analysis parameters in sperimental approach in order of 2% of range of motion (ROM) recorded 1 month after surgery. Based on this assumption sample size calculation will be conducted.
Detailed description
Rationale of the study is to evaluate through a prospective randomized controlled study if a modified direct superior approach (experimental approach) to the hip articulation which entirely spares i.e. avoids the sacrifice of the fascia lata (posterolateral approach) might elicit a better outcome in terms of gait, balance,strenghts recovery, clinical performance, patient reported outcome measurements and overall recovery time in patients undergoing TotalHipArthroplasty with the aid of dedicated, modified instrumentation in order to properly access this modified route.Two patients groups will randomly be allocated in one of the two group with a computer generated 1:1 randomization table.Total number of subjects participating in the study:50.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct superior approach | Experimental | Procedure: Direct Superior ApproachDirect superior approach 25 patients |
| posterolateral approach | Active comparator | Procedure: posterolateral approachposterolateral approach 25 patients |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Non-inflammatory degenerative joint disease, including osteoarthritis
- Patients in the age from 60 to 85 included
- Consenting to actively participate in the study and in the rehabilitation follow up program as foreseen by the study
- 18 ≤ Body Mass Index (BMI) ≥ 30 kg/m2
- patient without contralateral THA
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Direct Superior ApproachAlso: DSAGROUP II :Patients positioned in lateral decubitus.landmark for incision is the apex of the greater trochanter,and skin, subcutaneous tissue except fascia are incised accordingly. Fibers of gluteus will be separated and not incised.posterior capsulotomy is performed,;femur is dislocated and neck osteotomy carried out, followed by preparation of femoral canal with progressive broach. Acetabulum is prepared with burs of increasing diameter, and acetabular cup is impacted. A polyethylene insert and a femoral rasp are subsequently introduced.All remaining definitive implants can be positioned. | Procedure or surgery | direct superior approach |
| posterolateral approachGROUP I:patients are positioned in lateral decubitus.Landmark for incision is the apex of the greater trochanter.posterior capsulotomy is performed, femur is dislocated and neck osteotomy carried out, followed by preparation of femoral canal with progressive broach.Acetabulum is prepared with burs of increasing diameter,and acetabular cup is then impacted.All definitive implants can be positioned. | Procedure or surgery | posterolateral approach |
Primary outcome
evaluate spatiotemporal variables in meters among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
Time frame: Change from Baseline spatiotemporal variables in meters at 3 months
spatiotemporal variables: step length (meters), stride length (meters).
evaluate spatiotemporal variables in percentage among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
Time frame: Change from Baseline spatiotemporal variables in percentage at 3 months
Spatiotemporal variables: stance phase (percentage), swing phase (percentage)
evaluate kinematic parameters in degrees among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
Time frame: Change from Baseline Kinematic parameters in degrees at 3 months
Kinematic parameters (in degrees): hip flexion-extension ROM, hip abduction-adduction ROM, Hip rotation ROM, Hip Obliquity ROM.
1 secondary outcome
evaluation of instability with BEStest
Time frame: Change from Baseline BESTest at 3 months
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 24 Apr 2020.
- Derived from this study: PubMed 33410360Ulivi M, Orlandini L, Vitale JA, Meroni V, Prandoni L, Mangiavini L, Rossi N, Peretti GM. Direct superior approach versus posterolateral approach in total hip arthroplasty: a randomized controlled trial on early outcomes on gait, risk of fall, clinical and self-reported measurements. Acta Orthop. 2021 Jun;92(3):274-279. doi: 10.1080/17453674.2020.1865633. Epub 2021 Jan 7.
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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.
Michele Ulivi principal investigator
IRCCS Istituto Ortopedico GaleazziMilano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Superior Approach and posterolateral approach in people with Total Hip Arthroplasty and Hip Arthrosis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
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 11 inclusion and 0 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 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
evaluate spatiotemporal variables in meters among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing (time frame: Change from Baseline spatiotemporal variables in meters at 3 months). The study lists 3 primary outcomes in all. 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 NCT04358250, which also lists 1 linked publication.
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 24 Apr 2020.