Clinical trial NCT02648152: Polarstem Cementless Hip Stem
Official title: Multicenter Clinical Observation Using the Cementless Version of the POLARSTEM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in this multicenter clinical observation will have at least one of the indications listed below and meet all of the inclusion criteria. Patients meeting any of the exclusion criteria are not eligible for this study.

Indications

* Primary or secondary coxarthrosis
* Rheumatoid arthritis
* Developmental dysplasia of the hip (Crowe type I and II)
* Fracture or avascular necrosis of the femoral head

Brief summary: Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.

Detailed description: The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™.

Efficacy evaluations:

* Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) \[7, 8\], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
* Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration

Safety evaluations:

* Intra- and perioperative device-related adverse events (AE) and complications up to discharge
* Postoperative AE up to 10 years

Eligibility criteria: Inclusion Criteria:

* Patient has no general medical contraindication to surgery
* Informed consent to participate in the MCO signed by the patient
* Routine radiographic assessment is possible
* Patient is likely to comply with study follow-up requirements
* Primary total hip replacement (THR) to the affected side, unilateral or bilateral

Exclusion Criteria:

* Previously failed endoprosthesis and /or THR components in relevant hip
* History of infection in the affected joint; systemic infections
* Grossly insufficient femoral or acetabular bone stock in the involved hip
* Charcot joint disease or other severe neurosensory deficit
* Severe spinal disorders
* Age of patient at date of surgery \> 75 years
* High comorbidity
* Cemented acetabular cup

Primary outcomes:
measure: Long term survivorship of Polarstem
timeFrame: 10 years Follow Up after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: St. Elisabeth Hospital, Orthopedics and Rheumatology
city: Marburg
country: Germany
facility: University Marburg, Orthopedics and Rheumatology
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau, Orthopedics
Study officials:
affiliation: Philipps University Marburg
name: Turgay Efe, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cypres A, Fiquet A, Girardin P, Fitch D, Bauchu P, Bonnard O, Noyer D, Roy C. Long-term outcomes of a dual-mobility cup and cementless triple-taper femoral stem combination in total hip replacement: a multicenter retrospective analysis. J Orthop Surg Res. 2019 Nov 21;14(1):376. doi: 10.1186/s13018-019-1436-y.