Tissue Sparing Surgery in Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Hip Arthrosis; Total Hip Arthroplasty
• Interventions: Procedure: Direct Superior Approach; Procedure: posterolateral approach

• Registration Number: NCT04358250
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Study Timeline

• Study Start: 2017-04-26
• Primary Completion: 2017-10-25
• Study First Submitted: 2018-01-18
• Study Completion: 2018-11-30
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
direct superior approach	Direct Superior Approach	Direct superior approach 25 patients
posterolateral approach	posterolateral approach	posterolateral approach 25 patients

Primary Outcome Measures

Name	Time	Method
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	Change from Baseline spatiotemporal variables in meters at 3 months	spatiotemporal variables: step length (meters), stride length (meters).
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	Change from Baseline spatiotemporal variables in percentage at 3 months	Spatiotemporal variables: stance phase (percentage), swing phase (percentage)
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	Change from Baseline Kinematic parameters in degrees at 3 months	Kinematic parameters (in degrees): hip flexion-extension ROM, hip abduction-adduction ROM, Hip rotation ROM, Hip Obliquity ROM.

Secondary Outcome Measures

Name	Time	Method
evaluation of instability with BEStest	Change from Baseline BESTest at 3 months	BESTest (Balance Evaluation System Test) that evaluate the risk of fall . Each patient will be asked to wear a belt and two gloves containing the magnetic sensors and to follow the OAK device instruction.The portable device detects, on real time, the position and the orientation of each sensor. It yields a point-score from 0 to 24 and it has been shown that the relative optimal cut-off point was a 16 point-score out of 24: a point score between 17 and 24 classifies a subject as low risk who would otherwise be classified as being at medium/high risk (the duration will be approximately 10 minutes)

Trial Locations

Locations (2)

Istituto Ortopedico Galeazzi; 🇮🇹 Milano, Italy

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milan, Italy