Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty

• Sponsor: Clinic for Orthopedics Lovran (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06141928
• Collaborator: Special Hospital for Orthopedics Biograd na Moru (Other)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 52
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This study aimed to determine differences in functional recovery after total hip arthroplasty between a group of patients operated on using a direct lateral approach, an anterolateral minimally invasive approach, and a posterior approach to the hip joint.

Arthroplasty is the most commonly performed surgical procedure in orthopedics and is also considered the gold standard for treating the final stage of osteoarthritis. There are several different approaches, but there are still conflicting studies that talk about the benefits of a particular approach. There is an insufficient number of scientific, prospective studies that monitor the basic functional and rehabilitation parameters, which are also indicators of the success of the performed procedure.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty; Functional Recovery	Other: Functional recovery analysis	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty
• Actual Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Functional Recovery	Other: Functional recovery analysis; Functional recovery analysis with force evaluator & tester

Outcome Measures

Primary Outcome Measures

1. Functional recovery after total hip arthroplasty / Range of motion [2 years]

   Investigators analyze active and passive range of motion (ROM) measured in degrees.

2. Functional recovery after total hip arthroplasty / Walking speed [2 years]

   Investigators analyze walking speed in seconds for the 50 meters long walk.

3. Functional recovery after total hip arthroplasty / Harris Hip Score [2 years]

   Investigators take a questionnaire (Harris Hip Score, HHS), the maximum point is 100.

4. Functional recovery after total hip arthroplasty / Hip abductors strength [2 years]

   Investigators analyze hip abductors strength measured with a dynamometer in kilograms (kg).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• hip osteoarthritis

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic for Orthopeadics and Traumatology Lovran	Lovran	Primorsko-Goranska	Croatia	51145

Sponsors and Collaborators

• Clinic for Orthopedics Lovran
• Special Hospital for Orthopedics Biograd na Moru

Investigators

• Principal Investigator: Antea Buterin, MD, Clinic OL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antea Buterin, Head of Department, Clinic for Orthopedics Lovran
• ClinicalTrials.gov Identifier: NCT06141928
• Other Study ID Numbers: Clinic OL
• First Posted: Nov 21, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 21, 2023