Tissue Sparing Surgery in Total Hip Arthroplasty

NCT ID: NCT04358250

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2018-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

direct superior approach

Direct superior approach 25 patients

Group Type: EXPERIMENTAL

Direct Superior Approach

Intervention Type: PROCEDURE

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

posterolateral approach 25 patients

Group Type: ACTIVE_COMPARATOR

posterolateral approach

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

DSA

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Ulivi

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico GaleazziMilano

Locations

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Istituto Ortopedico Galeazzi

Milan, , Italy

Countries

Italy

References

Ulivi M, Orlandini L, Vitale JA, Meroni V, Prandoni L, Mangiavini L, Rossi N, Peretti GM. Direct superior approach versus posterolateral approach in total hip arthroplasty: a randomized controlled trial on early outcomes on gait, risk of fall, clinical and self-reported measurements. Acta Orthop. 2021 Jun;92(3):274-279. doi: 10.1080/17453674.2020.1865633. Epub 2021 Jan 7.

Reference Type: DERIVED

PMID: 33410360 (View on PubMed)

Other Identifiers

TSSINTHA2016

Identifier Type: -

Identifier Source: org_study_id