Leg Length and Quality of Life After Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

— EOS-PTH  

Official title:

Evaluation of Surgeon Performance to Restore Leg Length and Evaluation of the Quality of Life After Total Hip Replacement Related to the Reconstructed Anatomy With EOS Imaging System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437343
• Other study ID #: NI17039J
• Secondary ID: 2017-A03333-50
• Status: Completed
• Phase: N/A
• First received: February 2, 2018
• Last updated: February 12, 2018
• Start date: January 1, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: February 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study used 3D reconstructions from the EOS biplanar radiographic imaging system to perform leg length measurements before and after THA (Total hip arthroplasty) on all included THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after THA and the relationships between the quality of life, estimated by the HOOS score (Hip disability and osteoarthritis outcome score), and the anatomy of the new hip in standing position.

Description:

The study was conducted in patients who underwent a total hip arthroplasty in Lariboisiere Hospital, Paris, France, during the year 2015.

This retrospective study used 3D reconstructions from the EOS biplanar radiographic imaging system (EOS imaging, Paris, France) to perform leg length measurements before and after THA on all included THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after THA. Included patients either had hip osteoarthritis or femoral head osteonecrosis. Patients were excluded if they were undergoing revision surgery, or had a contralateral THA or total knee.

The performance of the surgeons was judged using the Cumulative Sum control chart (CUSUM) method.

Our objective was to study surgeon performance, measured by their ability to restore the initial preoperative length of the operated leg or to equalize the length of the two legs, and evaluate the relationships between the quality of life, estimated by the HOOS score, and the anatomy of the new hip in standing position using the EOS imaging system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• unilateral total hip replacement for osteoarthritis or avascular necrosis healthy contralateral hip

• age over 18 years

• informed consent to participate in the study

• radiographs obtained after total hip replacement using the EOS imaging system, filled HOOS form

• clinical follow-up of 12 months at least

Exclusion Criteria:

• past history of contralateral hip replacement

• ipsi or contralateral knee replacement

• hip arthroplasty performed using a Kerboull cross

• post-operative complications such as infection

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Procedure:
• Hip arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Région Ile de France, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anatomic lower limb length measurements between preoperative and postoperative measurements		preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)
Secondary	Change in flessum/recurvatum/HKS angle (hip knee shaft ) measurements, between preoperative and postoperative measurements		preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)
Secondary	HOOS score (Hip disability and osteoarthritis outcome score)	The outcome score consists of 40 items assessing 5 subscales. Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each.; To answer the questions, standardized answer options are given with scores from 0 to 4 (no, mild, moderate, severe and extreme).; To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms.; To calculate the total HOOS score the subscales need to be summed up, using following formula for all dimension.; 100 - [(patient's score of the subscale x 100)/(total score of the subscale)]	24 months after surgery