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The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty (HSS)

Primary Purpose

Hip Osteoarthritis, Muscle Weakness, Muscle Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lateral approach
Posterior approach
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring abductor, approach, limp, Trendelenburg, gluteus medius

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty.
  • Ability to understand and write swedish.

Exclusion Criteria:

  • Impaired funktion of the contralateral hip or knees causing limping.
  • Neuromuscular diseases
  • Postoperative leg length discrepancy excceding 1 cm
  • Postoperative discrepancy in femoral offset exceeding 25% of the femoral offset of the contralateral hip.

Sites / Locations

  • Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lateral approach

Posterior approach

Arm Description

290 participants receive their hip prosthesis through a lateral approach. The anterior third of m. gluteus medius along with the corresponding part of m. vastus lateralis are detached from the greater trochanter and the anterior capsule is excised for the exposure of the hip joint. After implant insertion, the gluteus medius is reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist.

290 participants receive their hip prosthesis through a posterior approach. The m. piriformis gemelli and obturator internus are detached from the greater trochanter and the posterior capsule is incised for the exposure of the hip joint. After implant insertion, the posterior capsule as well as m piriformis and the external rotators are reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist.

Outcomes

Primary Outcome Measures

Trendelenburg sign as binary variable (positive/negative)
Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.

Secondary Outcome Measures

Dislocation
Incidens of postoperative dislocation
Intraoperative blood loss
Bleeding during total hip arthroplasty measured in ml
Periprosthetic infection
Incidens of deep surgical wound infection
Oxford Hip Score
Patient-reported hip function measured in a scale of 0-48
Oxford Hip Score
Patient-reported hip function measured in a scale of 0-48
Euroqol 5 dimension 5 level index (EQ5D-5L)
Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1
Euroqol 5 dimension 5 level index (EQ5D-5L)
Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1
Euroqol visual analog scale (EQVAS)
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Euroqol visual analog scale (EQVAS)
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
University of California Activity Level (UCLA)
Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10
University of California Activity Level (UCLA)
Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10
Gluteus medius avulsion in ultrasound
The proportion avulsed gluteus medius tendon in relation to the whole tendon attachment in a scale of 0 (no avulsion) to 1 (total avulsion). Measured with ultrasound
Gluteus medius atrophy in Magnetic Resonance Imaging
The area of gluteus medius muscle in the operated side divided by the area of the gluteus medius muscle in the healthy side as shown in magnetic resonance imaging in a scale of 0 (complete atrophy) to 1 (no atrophy)
Hip abuction torque
Hip abuction torque measured in Nm/Kg with gate analysis
Trendelenburg sign as binary variable (positive/negative)
Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.

Full Information

First Posted
January 15, 2022
Last Updated
October 24, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT05216666
Brief Title
The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty
Acronym
HSS
Official Title
Abductor Insufficiency After Total Hip Arthroplasty; Risk Factors and Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Vastra Gotaland Region

4. Oversight

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

5. Study Description

Brief Summary
Residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. The purpose of this clinical trial is to compare the risk of residual limping one year after total hip arthropasty between lateral and posterior approach.
Detailed Description
The use of lateral approach has been empirically associated with increased risk of abductor insufficiency and limping after total hip arthroplasty compared with the posterior approach. However lateral approach remains a widespread technik because it provides a decreased risk of dislocation. In litterature, gluteus medius insufficiency has been reported even when the posterior approach has been used. In the early stage of postperative relhabilitation it is difficult to distinguish between between limping that resolves after abductor training and limping due to abductor injury/avulsion that is resistent to physiotherapy. The purpose of this randomized controlled trial is to compare the risk of persistent limping one year after total hip arthtoplasty between lateral and posterior approach and to identify patient-related risk factors for limping. Moreover it will validate ultra sound (U/S), magnetic resonance imaging (MRI) of the hip and gait analysis as diagnostic tools for early detection of limping that is going to persist one year after total hip arthroplasty. 580 patients will hip osteoarthritis be randomised to receive their total hip arthroplasty through an either lateral of posterior approach and will be followed at one year with physical examination (Trendelenburg sign) and patient.-reported outcome measures. Patients with a positive Trendelenburg sign at 3 months will undergo U/S and MRI examination as well as gait analysis and reassessed at one year with physical examination. The first 40 patients with negative Trendelenburg sign at 3 months will also undergo U/S, MRI and gait analysis. The specificity and sensitivity of U/S, MRI and gait analysis for positiv Trendelenburg sign will be calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Muscle Weakness, Muscle Atrophy, Muscle Injury, Arthroplasty Complications
Keywords
abductor, approach, limp, Trendelenburg, gluteus medius

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lateral approach
Arm Type
Active Comparator
Arm Description
290 participants receive their hip prosthesis through a lateral approach. The anterior third of m. gluteus medius along with the corresponding part of m. vastus lateralis are detached from the greater trochanter and the anterior capsule is excised for the exposure of the hip joint. After implant insertion, the gluteus medius is reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist.
Arm Title
Posterior approach
Arm Type
Active Comparator
Arm Description
290 participants receive their hip prosthesis through a posterior approach. The m. piriformis gemelli and obturator internus are detached from the greater trochanter and the posterior capsule is incised for the exposure of the hip joint. After implant insertion, the posterior capsule as well as m piriformis and the external rotators are reinserted into the greater trochanter with non-absorbable sutures. Participants are followed at three and 12 months by a physiotherapist.
Intervention Type
Procedure
Intervention Name(s)
Lateral approach
Other Intervention Name(s)
Gammer approach
Intervention Description
Total hip arthroplasty performed through a lateral surgical approach (Gammer)
Intervention Type
Procedure
Intervention Name(s)
Posterior approach
Other Intervention Name(s)
Moore approach
Intervention Description
Total hip arthroplasty performed through a posterior surgical approach (Moore)
Primary Outcome Measure Information:
Title
Trendelenburg sign as binary variable (positive/negative)
Description
Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.
Time Frame
At 12 months after intervention
Secondary Outcome Measure Information:
Title
Dislocation
Description
Incidens of postoperative dislocation
Time Frame
Within 12 months from intervention
Title
Intraoperative blood loss
Description
Bleeding during total hip arthroplasty measured in ml
Time Frame
Intraoperative
Title
Periprosthetic infection
Description
Incidens of deep surgical wound infection
Time Frame
Within 12 months from intervention
Title
Oxford Hip Score
Description
Patient-reported hip function measured in a scale of 0-48
Time Frame
At 3 months after intervention
Title
Oxford Hip Score
Description
Patient-reported hip function measured in a scale of 0-48
Time Frame
At 12 months after intervention
Title
Euroqol 5 dimension 5 level index (EQ5D-5L)
Description
Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1
Time Frame
At 3 months after intervention
Title
Euroqol 5 dimension 5 level index (EQ5D-5L)
Description
Patient-reported health-related quality of life measured with the swedish version of euroqol 5 dimension 5 level index 0-1
Time Frame
At 12 months after intervention
Title
Euroqol visual analog scale (EQVAS)
Description
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Time Frame
At 3 months after intervention
Title
Euroqol visual analog scale (EQVAS)
Description
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Time Frame
At 12 months after intervention
Title
University of California Activity Level (UCLA)
Description
Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10
Time Frame
At 3 months after intervention
Title
University of California Activity Level (UCLA)
Description
Patient-reported acivity level measured with the University of California Level of Acivity rank scale 0-10
Time Frame
At 12 months after intervention
Title
Gluteus medius avulsion in ultrasound
Description
The proportion avulsed gluteus medius tendon in relation to the whole tendon attachment in a scale of 0 (no avulsion) to 1 (total avulsion). Measured with ultrasound
Time Frame
At 3 months after intervention
Title
Gluteus medius atrophy in Magnetic Resonance Imaging
Description
The area of gluteus medius muscle in the operated side divided by the area of the gluteus medius muscle in the healthy side as shown in magnetic resonance imaging in a scale of 0 (complete atrophy) to 1 (no atrophy)
Time Frame
At 3 months after intervention
Title
Hip abuction torque
Description
Hip abuction torque measured in Nm/Kg with gate analysis
Time Frame
At 3 months after intervention
Title
Trendelenburg sign as binary variable (positive/negative)
Description
Trendelenburg sign negative if the pelvis remains horisontal while standing only on the operated leg with both arms in anatomical postion. If the pelvismcannot be kept horisontal and tilts towards the kontralateral hip the Trendelenburgs sign is regarded as positive.
Time Frame
At 3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty. Ability to understand and write swedish. Exclusion Criteria: Impaired funktion of the contralateral hip or knees causing limping. Neuromuscular diseases Postoperative leg length discrepancy excceding 1 cm Postoperative discrepancy in femoral offset exceeding 25% of the femoral offset of the contralateral hip.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgios Tsikandylakis, MD PhD
Phone
0046313421000
Email
tsikandylakis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Tsikandylakis, MD PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Mölndal
ZIP/Postal Code
431 80
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgios Tsikandylakis, MD, PhD
Phone
+46313421000
Email
tsikandylakis@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23039167
Citation
Hailer NP, Weiss RJ, Stark A, Karrholm J. The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis. An analysis of 78,098 operations in the Swedish Hip Arthroplasty Register. Acta Orthop. 2012 Oct;83(5):442-8. doi: 10.3109/17453674.2012.733919. Epub 2012 Oct 8.
Results Reference
background
PubMed Identifier
28440704
Citation
Zijlstra WP, De Hartog B, Van Steenbergen LN, Scheurs BW, Nelissen RGHH. Effect of femoral head size and surgical approach on risk of revision for dislocation after total hip arthroplasty. Acta Orthop. 2017 Aug;88(4):395-401. doi: 10.1080/17453674.2017.1317515. Epub 2017 Apr 25.
Results Reference
background
PubMed Identifier
31060427
Citation
Skoogh O, Tsikandylakis G, Mohaddes M, Nemes S, Odin D, Grant P, Rolfson O. Contemporary posterior surgical approach in total hip replacement: still more reoperations due to dislocation compared with direct lateral approach? An observational study of the Swedish Hip Arthroplasty Register including 156,979 hips. Acta Orthop. 2019 Oct;90(5):411-416. doi: 10.1080/17453674.2019.1610269. Epub 2019 May 7.
Results Reference
background
PubMed Identifier
30080985
Citation
Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6.
Results Reference
background
PubMed Identifier
31146555
Citation
Whiteside LA, Roy ME. Incidence and treatment of abductor deficiency during total hip arthroplasty using the posterior approach: repair with direct suture technique and gluteus maximus flap transfer. Bone Joint J. 2019 Jun;101-B(6_Supple_B):116-122. doi: 10.1302/0301-620X.101B6.BJJ-2018-1511.R1.
Results Reference
background
PubMed Identifier
22410129
Citation
Ewen AM, Stewart S, St Clair Gibson A, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture. 2012 May;36(1):1-6. doi: 10.1016/j.gaitpost.2011.12.024. Epub 2012 Mar 10.
Results Reference
background

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The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty

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