NCT06077825

Brief Summary

Objective: To assess the impact of total hip arthroplasty (THA) on functional outcomes and fall risk in patients with hip osteoarthritis. The objective was to investigate the effectiveness of physical therapy in postoperative rehabilitation and identify fall risk factors to guide fall prevention strategies after THA. Methods: A non-randomized, interventional clinical trial was conducted with 30 patients scheduled for THA. Functional outcomes were evaluated using the Harris Hip Score (HHS), 40-meter fast-paced walk test (40mFPWT), 30-Second Chair Test, and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). Balance and fall risk were assessed using the Single-Leg Standing Test and a posturography device (TETRAX). The Nottingham Health Profile (NHP) was used to measure subjective health status and quality of life. Assessments were performed preoperatively, at 6 weeks postoperatively, and at 3 months postoperatively.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2016

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

September 25, 2023

Last Update Submit

October 4, 2023

Conditions

Keywords

total hip arthroplastystatic balancepostoperative rehabilitation

Outcome Measures

Primary Outcomes (6)

  • Harris Hip Score (HHS)

    min-max (0-100) Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

    preoperative, postoperative 6 weeks and 3 months

  • 40-meter fast-paced walk test

    preoperative, postoperative 6 weeks and 3 months

  • 30-Second Chair Test

    preoperative, postoperative 6 weeks and 3 months

  • Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)

    It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain, Stiffness, Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

    preoperative, postoperative 6 weeks and 3 months

  • Static balance and fall risk

    It was assessed with Posturography device (TETRAX)

    preoperative, postoperative 6 weeks and 3 months

  • Single-Leg Standing Test

    preoperative, postoperative 6 weeks and 3 months

Secondary Outcomes (1)

  • The Nottingham Health Profile (NHP)

    preoperative, postoperative 6 weeks and 3 months

Study Arms (1)

experimental group

EXPERIMENTAL

30 patients who underwent total hip arthroplasty surgery took part in the experimental group.

Other: postoperative rehabilitation

Interventions

30 patients took postoperative rehabilitation after total hip arthroplasty surgery, 3 times a week, for 6 weeks. They took conventional rehabilitation (hip range of motion exercises, progressive strengthening exercises for hip and knee muscles, balance and proprioceptive exercises and gait training).

experimental group

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and radiographic evidence of unilateral hip osteoarthritis
  • Volunteering to participate in the study

You may not qualify if:

  • History of neurologic disorders affecting postural control (e.g., Parkinson disease)
  • Have other problems that affect balance, such as vertigo
  • Undergoing revision hip surgery
  • Osteoarthritis in the other lower extremity joints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Selvi Yüce, PhD(c)

    Acibadem Maslak Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 11, 2023

Study Start

July 15, 2015

Primary Completion

June 5, 2016

Study Completion

July 22, 2016

Last Updated

October 11, 2023

Record last verified: 2023-10