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Tissue Sparing Surgery in Total Hip Arthroplasty

Primary Purpose

Total Hip Arthroplasty, Hip Arthrosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Direct Superior Approach
posterolateral approach
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Hip Arthroplasty focused on measuring tissue sparing surgery

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Istituto Ortopedico Galeazzi
  • IRCCS Istituto Ortopedico Galeazzi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

direct superior approach

posterolateral approach

Arm Description

Direct superior approach 25 patients

posterolateral approach 25 patients

Outcomes

Primary Outcome Measures

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).
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)
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.

Secondary Outcome Measures

evaluation of instability with BEStest
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)

Full Information

First Posted
January 18, 2018
Last Updated
April 20, 2020
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT04358250
Brief Title
Tissue Sparing Surgery in Total Hip Arthroplasty
Official Title
Tissue Sparing Surgery in Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip Arthroplasty, Hip Arthrosis
Keywords
tissue sparing surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
direct superior approach
Arm Type
Experimental
Arm Description
Direct superior approach 25 patients
Arm Title
posterolateral approach
Arm Type
Active Comparator
Arm Description
posterolateral approach 25 patients
Intervention Type
Procedure
Intervention Name(s)
Direct Superior Approach
Other Intervention Name(s)
DSA
Intervention Description
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
Intervention Name(s)
posterolateral approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
spatiotemporal variables: step length (meters), stride length (meters).
Time Frame
Change from Baseline spatiotemporal variables in meters at 3 months
Title
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
Description
Spatiotemporal variables: stance phase (percentage), swing phase (percentage)
Time Frame
Change from Baseline spatiotemporal variables in percentage at 3 months
Title
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
Description
Kinematic parameters (in degrees): hip flexion-extension ROM, hip abduction-adduction ROM, Hip rotation ROM, Hip Obliquity ROM.
Time Frame
Change from Baseline Kinematic parameters in degrees at 3 months
Secondary Outcome Measure Information:
Title
evaluation of instability with BEStest
Description
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)
Time Frame
Change from Baseline BESTest at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Ulivi
Organizational Affiliation
IRCCS Istituto Ortopedico GaleazziMilano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Galeazzi
City
Milano
ZIP/Postal Code
20161
Country
Italy
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
ZIP/Postal Code
20161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
33410360
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.
Results Reference
derived

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Tissue Sparing Surgery in Total Hip Arthroplasty

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