A prospective randomised Rontgen Stereophotogrammatic Analysis (RSA) study using the uncemented Trident Tritanium acetabular component and the uncemented HA coated Symax hip stem in a single centre. Assessment of implant migration, bone remodeling and clinical function.

A prospective randomised Rontgen Stereophotogrammatic Analysis (RSA) study using the uncemented Trident Tritanium acetabular component and the uncemented HA coated Symax hip stem in a single centre. Assessment of implant migration, bone remodeling and clinical function. - Trident Tritanium and Symax RSA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44926

Enrollment

Registered

2011-04-14

Start date

2011-11-15

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hip osteoarthritis hip prosthesis

Interventions

All study patinets willbe implanted with an uncemented Trident HA coated or Trident Tritanium acetabulum component and an uncemented Symax HA coated hip prothesis. To adequately measure RSA a number

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients aged between 35 and 70 years Patients requiring uncemented primary THA Patients with a diagnosis of osteoarthritis, rheumatoid arthritis, avascular necrosis or post-traumatic arthritis

Exclusion criteria

Exclusion criteria: Patients who require a revision of previous implanted THA Patients with BMI>35 Patients who have had a prior procedure of femoral osteotomy patients with active or suspected infection patients with malignancy

Design outcomes

Primary

Measure	Time frame
The primary objective is to determine the prosthetic migration of the uncemented Trident acetabular component (Tritanium or HA coated (controls)) and the uncemented HA coated Symax stem from post-op until 2 years after implantation using the model based RSA technique.	—

Secondary

Measure	Time frame
The secondary objective of this study is to asses clinical outcome and patient satisfaction in patients implanted with the uncemented Trident acetabular component (Tritanium or HA coated (controls)) and the uncemented HA-coated Symax hip stem from post-op until 2 years after implantation using the Harris Hip Score, Oxford Hip Score, WOMAC and EQ-5D questionnaires at pre-op, 12w, 26w, 52w and 104w. The tertiary objective of this study is to assess bone remodeling of the uncemented Trident acetabular component (Tritanium or HA coated (controls)) and the uncemented HA-coated Symax hip stem from post-op until 2 years after implantation using QCT derived from using F18-Fluoride PET (Positron Emission Tomography) in a cohort of 12 consecutive patients (to be exact patients 11-23 in inclusion scheme) at 12, 26, 52 and 104 weeks post-op. The fourth objective of this study is to determine prosthetic migration and patient satisfaction at 5 years after surgery. A hip implant that is initially properly fixed to the bone, can show micromovement after some years. This can be a first sign of loosening, resulting in implant failure. So 5 year post-operative evaluation is important to confirm quality and safety of this implant as well as to determine the predictive capacity of RSA in terms of mid- and long term implant survival.	—

Measure

Time frame

The secondary objective of this study is to asses clinical outcome and patient satisfaction in patients implanted with the uncemented Trident acetabular component (Tritanium or HA coated (controls)) and the uncemented HA-coated Symax hip stem from post-op until 2 years after implantation using the Harris Hip Score, Oxford Hip Score, WOMAC and EQ-5D questionnaires at pre-op, 12w, 26w, 52w and 104w. The tertiary objective of this study is to assess bone remodeling of the uncemented Trident acetabular component (Tritanium or HA coated (controls)) and the uncemented HA-coated Symax hip stem from post-op until 2 years after implantation using QCT derived from using F18-Fluoride PET (Positron Emission Tomography) in a cohort of 12 consecutive patients (to be exact patients 11-23 in inclusion scheme) at 12, 26, 52 and 104 weeks post-op. The fourth objective of this study is to determine prosthetic migration and patient satisfaction at 5 years after surgery. A hip implant that is initially properly fixed to the bone, can show micromovement after some years. This can be a first sign of loosening, resulting in implant failure. So 5 year post-operative evaluation is important to confirm quality and safety of this implant as well as to determine the predictive capacity of RSA in terms of mid- and long term implant survival.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)