Clinical trial NCT04349046: Exception Cementless Hip Stem
Official title: Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Hip
Rheumatoid Arthritis
Inflammatory Arthritis
Congenital Hip Dysplasia
Avascular Necrosis of Hip
Femoral Neck Fractures
Keywords: Total hip arthroplasty
Medical device
Performance
Safety
Hip prosthesis
Clinical benefits
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant.

For this retrospective and prospective study, only the patients who had consented to the original data collection after their surgery will be contacted.

These the patients should be capable of understanding the surgeon's explanations and following his instructions, should be able and willing to participate in the last follow-up visit, and should give consent to take part in the study. The patients should meet all the inclusion criteria and none of the exclusion criteria.

Brief summary: This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.

Detailed description: Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant.

This study is an extension of the surgeons' data collection as an attempt from Zimmer-Biomet to fulfill its post-market surveillance obligations by recovering clinical data retrospectively and prospectively.

Study Procedure Flowchart - retrospective data collection: most patients had clinical follow-ups at pre-op, operative, immediate post-op, 3 Months, 1 year, 2, 3, 5, 7 years post-surgery during which their surgeons collected clinical data. This data will therefore only be collected by Zimmer-Biomet after the patients specifically consent to it.

Study Procedure Flowchart - prospective data collection: The informed consent signed by the patient for this study also allow Zimmer Biomet to collect the data of the standard clinical follow-up that will be conducted by the investigators at least 10 years post-surgery.

Eligibility criteria: At the time of surgery, the inclusion criteria were based on the indications presented in the IFUs:

* Primary or secondary osteoarthritis
* Inflammatory impairment of the hip, rheumatoid arthritis, etc.
* Fracture of the neck of the femur
* Avascular necrosis of the femoral head
* Sequelae from previous operations on the hip, osteotomies, etc.
* Congenital hip dysplasia.
* Patient is older than 18 years old
* Patient had consented to the original data collection after his/her surgery

At the time of surgery, the exclusion criteria were based on the contraindications presented in the IFUs:

* Local or systemic infections.
* Serious muscular, neurological or vascular deficiencies in the limb concerned.
* Bone destruction or poor quality bone likely to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
* Any concomitant disorder likely to affect the function of the implant.
* Allergy to one of the implant components.
* Patients weighing more than 110 kg.
* Patient incapable of following the recommendations of the surgeon

Primary outcomes:
measure: Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
timeFrame: 10 years post-surgery
Secondary outcomes:
measure: Pain and functional performance based on the Harris Hip Score
timeFrame: 10 years post-surgery
measure: Subject quality-of-life determined by the EQ-5D (EuroQoI) score
timeFrame: 10 years post-surgery
measure: X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
timeFrame: 10 years post-surgery
measure: Safety based on eventual complications occurred including dislocations and revisions/removals
timeFrame: 10 years post-surgery]
Other outcomes:
Locations:
city: Aye
country: Belgium
facility: Hôpital Princesse Paola
city: Contamine-sur-Arve
country: France
facility: CH Alpes Léman
city: Hyères
country: France
facility: Hopital Renee Sabran
city: Nîmes
country: France
facility: Clinique Basseres Kacem-Boudhar
city: Thonon-les-Bains
country: France
facility: Hôpitaux Du Léman
city: Épagny
country: France
facility: CH Annecy Genevois
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: