NCT04358250

Tissue Sparing Surgery in Total Hip Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2017-04-26
• Primary completion: 2017-10-25
• Completion: 2018-11-30
• First posted: 2020-04-24
• Last updated: 2020-04-24

Locations

2 sites across 1 country: Italy