Exception Cementless Hip Stem

N/AActive Not RecruitingNCT04349046

Zimmer Biomet332 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

332

Conditions

Osteoarthritis, Hip Rheumatoid Arthritis Inflammatory Arthritis Congenital Hip Dysplasia Avascular Necrosis of Hip Femoral Neck Fractures

Interventions

Total hip arthoplasty (THA)DEVICE

Total hip arthroplasty (THA) is a common operative treatment where an arthritic, degenerative or fractured hip joint is replaced with a prosthetic device if conservative options are unable to relieve pain and debilitating symptoms. THA was traditionally performed on patients over 60 years old, but now includes young and active patients, as well as very old ones thanks to the continuous improvement in implant design. Major indications of THA include osteoarthritis, rheumatoid arthritis, avascular necrosis and hip fractures. The THA surgical procedure involves replacing the head of the femur and acetabulum or socket with an artificial prosthesis. This system is composed of a femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral stem, and an acetabular component or shell that replaces the acetabulum.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (6)

Hôpital Princesse Paola

Aye, Belgium

CH Alpes Léman

Contamine-sur-Arve, France

CH Annecy Genevois

Épagny, France

Hopital Renee Sabran

Hyères, France

Outcomes

Primary Outcomes

Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method

Time frame: 10 years post-surgery

Secondary Outcomes

Pain and functional performance based on the Harris Hip Score

The score is given from 0 to 100 with Excellent: 90 - 100, Good: 80 - 89, Fair: 70 - 79, and Poor: \< 70

Time frame: 10 years post-surgery

Subject quality-of-life determined by the EQ-5D (EuroQoI) score

The lowest score (0) corresponds to "the worst health the patient can imagine", and the highest rate (100) corresponds to "the best health he can imagine".

Time frame: 10 years post-surgery

X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc

Time frame: 10 years post-surgery

Safety based on eventual complications occurred including dislocations and revisions/removals

Time frame: 10 years post-surgery]

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.