Comparison of a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem

Osteoarthritis, Hip Clinical Trial

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Official title:

Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03500926
• Other study ID #: 2017-A03215-48
• Status: Recruiting
• Phase: N/A
• First received: March 9, 2018
• Last updated: April 10, 2018
• Start date: March 9, 2018
• Est. completion date: March 9, 2025

Study information

• Verified date: March 2018
• Source: Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
• Contact: David BIAU, MD
• Phone: +33158413037
• Email: secretatiat.biau.cch[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.

Description:

This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.

Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 9, 2025
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hip osteoarthritis requiring a total hip replacement

• >18 years old

• agrees to participate

Exclusion Criteria:

• total hip replacement not indicated

• general anesthesia contraindicated

• previous surgery on the ipsilateral femur

• follow-up not possible

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• total hip replacement - standard femoral stem
total hip replacement with standard femoral stem
• total hip replacement - short femoral stem
total hip replacement with short femoral stem

Locations

Country	Name	City	State
France	Hopital Cochin	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intraoperative proportion of patients requiring a blood transfusion	proportion of patients requiring a blood transfusion during the procedure	at time of hospital discharge, at approximately 2 days
Other	postoperative PMA (Postel Merle d'Aubigné) score after hospital discharge	PMA score	3 months, 1 year, 2 years, 5 years
Other	postoperative Oxford hip score after hospital discharge	oxford hip score	3 months, 1 year, 2 years, 5 years
Other	scar assessement	patient specific index	3 months, 1 year, 2 years, 5 years
Other	hip pain	measurement of hip pain on a Likert scale	3 months, 1 year, 2 years, 5 years
Other	thigh pain	measurement of thigh pain on a Likert scale	3 months, 1 year, 2 years, 5 years
Other	revision of hip replacement	cumulative incidence of revision at 5 years (Cox model)	at 5 years
Other	radiological outcome - engh score	Engh score	2 years
Other	radiological outcome - ARA (AGORA Roentgenographic Assessment) score	ARA score	2 years
Other	in hospital morphine consumption	total dose of morphine used in recovery room and until day one	postop day 1
Other	in hospital blood transfusion	proportion of patients requiring a blood transfusion during hospitalisation	until discharge from hospital, at approximately 2 days
Other	duration of hospital stay	length of hospitalisation in days	until discharge from hospital, at approximately 2 days
Primary	stem subsidence	stem subsidence will be measured using the EBRA (Ein-Bild-Rontgen-analyse) software on postoperative antero-posterior radiographs (5 xrays from day one to year 2)	2 years postop
Secondary	Intraoperative surgeon satisfaction	measurement of surgeon's satisfaction with using the instrumentation to insert the stem; on a Likert scale intraoperative complication	intraoperative