Tissue Sparing Surgery in Total Hip Arthroplasty

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Completed

Conditions: Total Hip Arthroplasty; Hip Arthrosis

Treatments: Procedure: posterolateral approach; Procedure: Direct Superior Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT04358250

TSSINTHA2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

direct superior approach

Experimental group

Description:

Direct superior approach 25 patients

Treatment:

Procedure: Direct Superior Approach

posterolateral approach

Active Comparator group

Description:

posterolateral approach 25 patients

Treatment:

Procedure: posterolateral approach