POLARSTEM Cementless Hip Stem

NCT02648152 | Completed Results DMC

• 1 other identifier: D10070-1
• Study Type: observational
• Target: 218
• Locations: 2 countries
• Sites: 3

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM

  Overall survivorship of the Cementless Version of the POLARSTEM pre-operatively, 3 months, 12 months, 12 months, 36 months, 60 months, and 120 months by Kaplan-Meier estimate with overall hip survivorship defined as the time between date of treatment and date of revision for any reason.

  Pre-operatively, 3 months, 12 months, 36 months, 60 months, and 120 months

Secondary Outcomes (10)

• Harris Hip Score (HHS)

  Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale

  Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale

  Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale

  Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score

  Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months

Interventions

Total Hip Arthroplasty DEVICE

Total Hip Arthroplasty using Cementless version of the POLARSTEM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (3)

St. Elisabeth Hospital, Orthopedics and Rheumatology

Bochum, 44787, Germany

Location

University Marburg, Orthopedics and Rheumatology

Marburg, Germany

Location

Kantonsspital Aarau, Orthopedics

Aarau, 5001, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31752951 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Director Clinical Operations - EU
• Organization: Smith + Nephew plc

annelaine.tomlinson@smith-nephew.com

00441923 477100

Study Officials

• Turgay Efe, Dr.med.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 6, 2016
• Study Start: March 1, 2009
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); CH (1)