Randomized Study of Surgical Approach of Total Hip Arthroplasty (THA).
ConditionHip Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorUppsala University
About this trial
This study intends to analyze the healing process of the hip muscle system and to evaluate the functional recovery score after performing a cemented primary THA for osteoarthritis (OA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
hip osteoarthritis as indication for THA surgery
use of cemented prosthetic Components
Disqualifiers
symptomatic osteoarthritis on the contralateral hip
neuromuscular disorder
dementia
BMI>40
Trial design
Design model
Parallel
Treatments tested in this trial
Total hip arthroplasty
Procedure/SurgeryMarking of surgically detached tendons with metall markers. Radiostereometric analysis of the migration of the metall markers in different time points after surgery to evaluate healing or no healing of the tendons.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Direct lateral incisionActive comparator 1 intervention
Group B: Posterolateral incisionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hip abduction and external rotation strength in THA using direct lateral approach
Hip abduction and external rotation muscle strength following THA using a direct lateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the direct lateral approach, strength outcomes will be compared according to postoperative gluteus medius tendon healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.
Time frame
Muscle strength preoperatively, at 3 months and 1 year after surgery.2
Hip abduction and external rotation strength in THA using posterolateral approach
Hip abduction and external rotation muscle strength following THA using a posterolateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. In participants undergoing THA through the posterolateral approach, strength outcomes will be compared according to postoperative piriformis healing status (healed vs non-healed), as assessed by CTMA. Tendon retraction on CTMA will be used to classify tendon healing status.
Time frame
Muscle strength preoperatively, at 3 months and 1 year after surgery.3
Patient experiences based on interviews.
A qualitative content analysis will be performed to explore patients' experiences of the undergoing surgical procedure and the rehabilitation period, including thoughts, concerns, emotions, and expectations related to recovery and the social environment.
Time frame
Interview 1 year after surgery.Secondary outcomes
1
Hip abduction and external rotation strength in THA using direct lateral or posterolateral approach
Hip abduction and external rotation muscle strength following THA using a direct lateral or a posterolateral approach will be assessed using a handheld dynamometer. Strength of the operated hip will be compared with the contralateral hip and expressed as a strength ratio. Strength outcomes will be compared between the two groups (direct lateral and posterolateral).
Time frame
Muscle strength preoperatively, at 3 months and 1 year after surgery.2
Clinical score evaluation using Harris Hip Score (HHS) inquiry.
Comparison of HHS (0-100 rating scale, where higher scores indicate less disability and better hip health) between the two surgical approach groups (direct lateral and posterolateral approach) and between subgroups defined by tendon healing status (healed vs non-healed).
Time frame
HHS preoperatively, at 6 weeks and 1 year after surgery.3
Presence of Trendelenburg gait on clinical examination
The presence or absence of Trendelenburg gait will be assessed by clinical examination after total hip arthroplasty. The frequency of Trendelenburg gait will be compared between the two surgical approach groups (direct lateral approach and posterior approach). Trendelenburg gait will also be compared between subgroups defined by postoperative tendon healing status (healed vs non-healed), as assessed by computed tomography motion analysis (CTMA).
Time frame
Preoperatively, at 6 weeks and 1 year after surgery.4
Comparison of patient health satisfaction as defined with the inquiry SF-36.
Comparison of SF-36 outcomes between the two surgical approach groups (direct lateral and posterior approach) and between subgroups defined by tendon healing status (healed vs non-healed).
Time frame
SF-36 preoperatively, at 3 months and 1 year after surgery.Sponsors and contacts
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Source ClinicalTrials.gov