- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04358250
Tissue Sparing Surgery in Total Hip Arthroplasty
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Milan, Italy, 20161
- IRCCS Istituto Ortopedico Galeazzi
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Milano, Italy, 20161
- Istituto Ortopedico Galeazzi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:- Patients affected by:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: direct superior approach
Direct superior approach 25 patients
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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.
Other Names:
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Active Comparator: posterolateral approach
posterolateral approach 25 patients
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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spatiotemporal variables: step length (meters), stride length (meters).
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Change from Baseline spatiotemporal variables in meters at 3 months
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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)
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Change from Baseline spatiotemporal variables in percentage at 3 months
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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
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Kinematic parameters (in degrees): hip flexion-extension ROM, hip abduction-adduction ROM, Hip rotation ROM, Hip Obliquity ROM.
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Change from Baseline Kinematic parameters in degrees at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluation of instability with BEStest
Time Frame: Change from Baseline BESTest at 3 months
|
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)
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Change from Baseline BESTest at 3 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TSSINTHA2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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