Tissue Sparing Surgery in Total Hip Arthroplasty

NCT04358250 | Completed

• 1 other identifier: TSSINTHA2016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Total Hip Arthroplasty; Hip Arthrosis

Keywords

tissue sparing surgery

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• evaluation of instability with BEStest

  Change from Baseline BESTest at 3 months

Study Arms (2)

direct superior approach

EXPERIMENTAL

Direct superior approach 25 patients

Procedure: Direct Superior Approach

posterolateral approach

ACTIVE COMPARATOR

posterolateral approach 25 patients

Procedure: posterolateral approach

Interventions

Direct Superior Approach 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.

Also known as: DSA

direct superior approach

posterolateral approach 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.

posterolateral approach

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≤ Body Mass Index (BMI) ≥ 30 kg/m2
• patient without contralateral THA

You may not qualify if:

• 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)

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (2)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

Istituto Ortopedico Galeazzi

Milan, 20161, Italy

Location

Related Publications (1)

• 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.

  PMID: 33410360 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michele Ulivi

  IRCCS Istituto Ortopedico GaleazziMilano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: April 24, 2020
• Study Start: April 26, 2017
• Primary Completion: October 25, 2017
• Study Completion: November 30, 2018
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

IT (2)