Total Hip Arthroplasty Clinical Trial
Official title:
Tissue Sparing Surgery in Total Hip Arthroplasty
Verified date | April 2020 |
Source | Istituto Ortopedico Galeazzi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | November 30, 2018 |
Est. primary completion date | October 25, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Istituto Ortopedico Galeazzi | Milan | |
Italy | Istituto Ortopedico Galeazzi | Milano |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Galeazzi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Change from Baseline spatiotemporal variables in meters at 3 months | |
Primary | 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) | Change from Baseline spatiotemporal variables in percentage at 3 months | |
Primary | 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. | Change from Baseline Kinematic parameters in degrees at 3 months | |
Secondary | 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) | Change from Baseline BESTest at 3 months |
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