Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04358250
Other study ID # TSSINTHA2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 26, 2017
Est. completion date November 30, 2018

Study information

Verified date April 2020
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

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)

Study Design


Intervention

Procedure:
Direct Superior Approach
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 approach
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.

Locations

Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan
Italy Istituto Ortopedico Galeazzi Milano

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

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
See also
  Status Clinical Trial Phase
Terminated NCT02818894 - Spinal Anesthesia in Total Hip Arthroplasty Phase 4
Completed NCT02242201 - Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular Phase 4
Completed NCT02414542 - Minima Clinical Study
Completed NCT01817010 - Strength and Function Following Total Hip Arthroplasty N/A
Completed NCT01443975 - Clinical Evaluation on the Use of the X-pander Device N/A
Recruiting NCT05530174 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture N/A
Recruiting NCT05530551 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA N/A
Recruiting NCT06141928 - Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty N/A
Recruiting NCT05054192 - Reliability and Validity of Modified Four Square Step Test
Recruiting NCT04492462 - The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery N/A
Withdrawn NCT02926651 - Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty Phase 4
Completed NCT02308813 - Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip N/A
Recruiting NCT02032017 - Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation. N/A
Recruiting NCT01312077 - The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement Phase 4
Withdrawn NCT01380665 - Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty Phase 4
Recruiting NCT05893563 - Corail Stability at 5-Years Post-Total Hip Arthroplasty
Recruiting NCT06088069 - Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty N/A
Active, not recruiting NCT03210844 - The Clinical Outcomes After Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty N/A
Recruiting NCT04801680 - Mpact 3D Metal Cup PMS
Terminated NCT02006251 - Real-Time Instrument for Acetabular Shell Positioning