Ireland
--:--IST
Recruiting Not applicable

Randomized Study of Surgical Approach of Total Hip Arthroplasty (THA).

NCT07851597 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2021-03-01
Last updated
2026-10-01

Condition(s) studied

Hip Arthroplasty

Investigational drug(s) / intervention(s)

Total hip arthroplasty

Total hip arthroplasty: Marking 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.

Study summary

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

Sex
ALL
Min age
60 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * hip osteoarthritis as indication for THA surgery * use of cemented prosthetic Components Exclusion Criteria: * symptomatic osteoarthritis on the contralateral hip * neuromuscular disorder * dementia * BMI\>40 * previous surgery on any hip

Primary outcome measure(s)

  • Hip abduction and external rotation strength in THA using direct lateral approach — Muscle strength preoperatively, at 3 months and 1 year after surgery.
    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.
  • Hip abduction and external rotation strength in THA using posterolateral approach — Muscle strength preoperatively, at 3 months and 1 year after surgery.
    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.
  • Patient experiences based on interviews. — Interview 1 year after surgery.
    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.

Trial sites (1)

FacilityCityRegionStatus
Gävle hospital orthopaedic clinic Gävle Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07851597 on ClinicalTrials.gov ↗ ← All trials in Sweden