Clinical trial NCT05093361: Randomized Controlled Trial of Total Hip Arthroplasty
Official title: Randomized Controlled Trial of Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthritis
Total Hip Arthroplasty (THA)
Keywords: Hip Arthritis
Total Hip Arthroplasty
THA
Conservative Treatment
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of total hip arthroplasty and conservative treatment to hip pain, to activities of daily life and to the quality of life in patients with hip osteoarthritis.

Detailed description: The purpose of this randomized controlled study is to compare the effect of total hip arthroplasty and conservative treatment (that consists of self-driven exercises that physical therapists teach to the patients) to hip pain, to activities of daily life and to the quality of life in patients with hip osteoarthritis. Also the ill effects and cost effectiveness of total hip arthroplasty and conservative treatment are evaluated. Further more the aim is to investigate if total hip arthroplasty alleviates osteoarthritic pain in 12-month follow-up and if it enhances performance and quality of life.

Eligibility criteria: Inclusion Criteria:

* Hip osteoarthritis that is in X-ray pictures ≥2 in Kellgren - Lawrence classification
* Primary osteoarthritis
* Patients symptoms of hip osteoarthritis are so severe, that an experienced orthopedist would suggest total hip arthroplasty as a treatment

Exclusion Criteria:

* Patients symptoms are so severe that total hip arthroplasty should be done within the next three months
* ASA \> 3 (ASA physical status classification system)
* Normal contraindications to surgery
* Previous surgery to the same hip that has the osteoarthritis (including total hip arthroplasty, surgery for fracture, osteotomy, arthroscopy)
* The referring orthopedist has placed the patient in line for hip arthroplasty
* Secondary osteoarhritis

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: From baseline to one year
measure: Harris Hip Score (HHS)
timeFrame: From baseline to one year
Secondary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Pain
timeFrame: From baseline to one year
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Stiffness
timeFrame: From baseline to one year
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Physical Function
timeFrame: From baseline to one year
measure: 30s Chair Stand Test
timeFrame: From baseline to one year
measure: 40m Fast-paced Walk Test
timeFrame: From baseline to one year
measure: Stair Climb Test
timeFrame: Baseline to one year
measure: Grip Strength
timeFrame: Baseline to one year
measure: Short Form 36 Health Survey Questionnaire (SF-36)
timeFrame: Baseline to one year
measure: painDetect
timeFrame: Baseline to one year
measure: BMI
timeFrame: Baseline to one year
measure: Use of pain medication
timeFrame: Baseline to one year
measure: Training diary
timeFrame: Baseline to one year
measure: Range of motion in hip extension
timeFrame: Baseline to one year
measure: Range of motion in hip flexion
timeFrame: Baseline to one year
measure: Range of motion in hip inner rotation
timeFrame: Baseline to one year
measure: Range of motion in hip outer rotation
timeFrame: Baseline to one year
measure: Leg length discrepancy
timeFrame: Baseline to one year
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Pohjois-Savo
Study officials:
affiliation: Kuopio University Hospital
name: Aapo Talonpoika
role: PRINCIPAL_INVESTIGATOR
affiliation: Kuopio University Hospital and Helsinki University Hospital
name: Jari Arokoski
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital
name: Lauri Karttunen
role: PRINCIPAL_INVESTIGATOR
affiliation: Zürcher Hochschule für Angewandte Wissenschaften ZHAW Departement Gesundheit, Institut für Physiotherapie
name: Hannu Luomajoki
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital
name: Jukka Huopio
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital
name: Antti Jaroma
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital
name: Joonas Sirola
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital
name: Heikki Kröger
role: STUDY_CHAIR
References: