Randomized Controlled Trial of Total Hip Arthroplasty

NCT ID: NCT05093361

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2023-01-20

Brief Summary

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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

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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.

Conditions

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Hip Arthritis Total Hip Arthroplasty (THA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Operative Treatment

Total Hip Arthroplasty

Group Type ACTIVE_COMPARATOR

Total Hip Arthroplasty

Intervention Type PROCEDURE

Total Hip Arthroplasty for the treatment of hip arthritis.

Conservative Treatment

Physical therapy

Group Type ACTIVE_COMPARATOR

Physical Therapy

Intervention Type PROCEDURE

Self-driven training according to the training plan instructed by physical therapist.

Interventions

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Total Hip Arthroplasty

Total Hip Arthroplasty for the treatment of hip arthritis.

Intervention Type PROCEDURE

Physical Therapy

Self-driven training according to the training plan instructed by physical therapist.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aapo Talonpoika

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Jari Arokoski

Role: STUDY_DIRECTOR

Kuopio University Hospital and Helsinki University Hospital

Lauri Karttunen

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Hannu Luomajoki

Role: STUDY_DIRECTOR

Zürcher Hochschule für Angewandte Wissenschaften ZHAW Departement Gesundheit, Institut für Physiotherapie

Jukka Huopio

Role: STUDY_DIRECTOR

Kuopio University Hospital

Antti Jaroma

Role: STUDY_DIRECTOR

Kuopio University Hospital

Joonas Sirola

Role: STUDY_DIRECTOR

Kuopio University Hospital

Heikki Kröger

Role: STUDY_CHAIR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

Other Identifiers

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5203108

Identifier Type: -

Identifier Source: org_study_id

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