Clinical trial NCT04358250: Tissue Sparing Surgery in Total Hip Arthroplasty
Official title: Tissue Sparing Surgery in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Hip Arthrosis
Keywords: tissue sparing surgery
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: Change from Baseline spatiotemporal variables in meters at 3 months
measure: 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
timeFrame: Change from Baseline spatiotemporal variables in percentage at 3 months
measure: 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
timeFrame: Change from Baseline Kinematic parameters in degrees at 3 months
Secondary outcomes:
measure: evaluation of instability with BEStest
timeFrame: Change from Baseline BESTest at 3 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Ortopedico Galeazzi
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico GaleazziMilano
name: Michele Ulivi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.