Randomized Controlled Trial of Total Hip Arthroplasty

NCT05093361 | Completed DMC

• 1 other identifier: 5203108
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthritis; Total Hip Arthroplasty (THA)

Keywords

Hip Arthritis; Total Hip Arthroplasty; THA; Conservative Treatment

Outcome Measures

Primary Outcomes (2)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. Higher scores indicate worse pain, stiffness, and functional limitations.

  From baseline to one year

• Harris Hip Score (HHS)

  The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty. Four subscales make up HHS. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The survey has 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.

  From baseline to one year

Secondary Outcomes (17)

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Pain

  From baseline to one year

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Stiffness

  From baseline to one year

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Sub Score Physical Function

  From baseline to one year

• 30s Chair Stand Test

  From baseline to one year

• 40m Fast-paced Walk Test

  From baseline to one year

Study Arms (2)

Operative Treatment

ACTIVE COMPARATOR

Total Hip Arthroplasty

Procedure: Total Hip Arthroplasty

Conservative Treatment

ACTIVE COMPARATOR

Physical therapy

Procedure: Physical Therapy

Interventions

Total Hip Arthroplasty PROCEDURE

Total Hip Arthroplasty for the treatment of hip arthritis.

Operative Treatment

Physical Therapy PROCEDURE

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

Conservative Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Therapeutics; Rehabilitation

Study Officials

• Aapo Talonpoika

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

• Jari Arokoski

  Kuopio University Hospital and Helsinki University Hospital

  STUDY DIRECTOR

• Lauri Karttunen

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

• Hannu Luomajoki

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

  STUDY DIRECTOR

• Jukka Huopio

  Kuopio University Hospital

  STUDY DIRECTOR

• Antti Jaroma

  Kuopio University Hospital

  STUDY DIRECTOR

• Joonas Sirola

  Kuopio University Hospital

  STUDY DIRECTOR

• Heikki Kröger

  Kuopio University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: October 26, 2021
• Study Start: September 1, 2017
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: March 23, 2023

Record last verified: 2022-04

Locations

FI (1)