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Pre and Postoperative Gait Analysis of Randomized Patient to 2 Different Cement Fixation Methods

Pre and Postoperative Gait Analysis of Randomized Patients to 2 Different Cement Fixation Methods

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04788719
Enrollment
50
Registered
2021-03-09
Start date
2018-01-01
Completion date
2021-03-01
Last updated
2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait Analysis, Hip Arthritis, Total Hip Arthroplasty

Brief summary

The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Two different cement fixation methods are used in order to insert THR implants. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. Gait analysis preoperative and 2 year after surgery.

Detailed description

The primary goal of Total Hip Replacement (THR) surgery in the treatment of hip osteoarthritis is to reduce pain and restore hip function in order to increase patient mobility and quality of life. Patients with radiological signs of osteoarthritis of the hip, hip pain and functional disability may be treated with insertion of a THA. Two different fixation methods are used in order to insert THR implants. Cemented fixation using bone cement, polymethyl methacrylate (PMMA) is the most commonly used fixation method in Sweden. A new bone cement, Refobacin®, already marketed in Germany is planned to be introduced in Sweden in late 2018. The hospital is also equipped with a modern gait laboratory were the functional gait performance can be evaluated. This will be done before and after surgery in 2 groups randomized to either of 2 cement fixation methods. The subjects will undergo gait analysis befor and 2 year after surgery.

Interventions

OTHERGait analysis

Gait analysis

Sponsors

Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Preop Postop

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* hip arthritis

Exclusion criteria

* no hip arthritis

Design outcomes

Primary

MeasureTime frameDescription
KinematicsPreopHip angels in 3 planes

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026