Back to results

Symax International Study

Primary Purpose

Hip Osteoarthritis, Prosthesis Durability

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Symax uncemented hip stem

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients requiring uncemented primary total hip arthroplasty (osteoarthritis, avascular necrosis and/or post-traumatic arthritis), age between 18-70 years, BMI less or equal to 35.

Exclusion Criteria:

Patients with bilateral hip complaints, impaired cognitive function and use of medication or illness influencing bone metabolism.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Symax uncemented hip stem

Arm Description

The Symax hip stem is an uncemented design forged from Ti6Al4V alloy (Stryker EMEA). Primary mechanical stability is provided by anatomical metaphyseal geometry. The hip stem features a size dependent anteversion, neck length and offset, with a CCD angle of 128°. Secondary biological stability is accomplished by fast osseous integration due to the BONIT-HA coating on the metaphyseal part of the stem.

Outcomes

Primary Outcome Measures

Change of Harris Hip Score (HHS) during follow-up

A hip specific functional score

Secondary Outcome Measures

Radiographic evaluations

Radiographic evaluations per Gruen zone and comparison between two assessment teams

Full Information

NCT ID

NCT03469687

First Posted

January 15, 2018

Last Updated

March 16, 2018

Sponsor

Maastricht University Medical Center

Collaborators

Vejle Hospital, Stryker Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT03469687

Brief Title

Symax International Study

Official Title

5 Year Clinical and Radiographic Follow-up of the Uncemented Symax Hip Stem in an International Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 2, 2004 (Actual)

Primary Completion Date

October 11, 2010 (Actual)

Study Completion Date

October 11, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

Collaborators

Vejle Hospital, Stryker Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip in an international clinical study with 5 years of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Osteoarthritis, Prosthesis Durability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Symax uncemented hip stem

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Symax uncemented hip stem

Primary Outcome Measure Information:

Title

Change of Harris Hip Score (HHS) during follow-up

Description

A hip specific functional score

Time Frame

Preoperative HHS and postoperatively change in HHS at 6 months, 1 year, 2 years, 3 years and 5 years

Secondary Outcome Measure Information:

Title

Radiographic evaluations

Description

Radiographic evaluations per Gruen zone and comparison between two assessment teams

Time Frame

Immediately postoperative radiograhpic evaluation as baseline and changes in radiography at follow-up 6 months, 1 year, 2 years, 3 years and 5 years we evaluated the radiograhip evaluations again

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients requiring uncemented primary total hip arthroplasty (osteoarthritis, avascular necrosis and/or post-traumatic arthritis), age between 18-70 years, BMI less or equal to 35. Exclusion Criteria: Patients with bilateral hip complaints, impaired cognitive function and use of medication or illness influencing bone metabolism.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22383318

Citation

ten Broeke RH, Hendrickx RP, Leffers P, Jutten LM, Geesink RG. Randomised trial comparing bone remodelling around two uncemented stems using modified Gruen zones. Hip Int. 2012 Jan-Feb;22(1):41-9. doi: 10.5301/HIP.2012.9103.

Results Reference

result

PubMed Identifier

21586774

Citation

ten Broeke RH, Alves A, Baumann A, Arts JJ, Geesink RG. Bone reaction to a biomimetic third-generation hydroxyapatite coating and new surface treatment for the Symax hip stem. J Bone Joint Surg Br. 2011 Jun;93(6):760-8. doi: 10.1302/0301-620X.93B6.24986.

Results Reference

result

PubMed Identifier

30064453

Citation

Kruijntjens DSMG, Kjaersgaard-Andersen P, Revald P, Leonhardt JS, Arts JJC, Ten Broeke RHM. 5-year clinical and radiographic follow-up of the uncemented Symax hip stem in an international study. J Orthop Surg Res. 2018 Jul 31;13(1):191. doi: 10.1186/s13018-018-0888-9.

Results Reference

derived

Learn more about this trial

Symax International Study

We'll reach out to this number within 24 hrs