Clinical trial NCT03409666: Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Official title: Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Noninflammatory Degenerative Joint Disease
Avascular Necrosis
Correction of Functional Deformity
Rheumatoid Arthritis
Keywords: Total Hip Arthroplasty
Medical Device
Performance
Safety
Hip prosthesis
Roentgen Stereophotogrammetric Analysis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 assignment of treatment
Primary purpose: TREATMENT

Brief summary: This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.

Detailed description: A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.

All potential study subjects will be required to participate in the Informed Consent process.

Eligibility criteria: Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
* Correction of functional deformity.
* Male or female

  -≥ 18 and ≤ 70 years of age
* Subjects willing to return for follow-up evaluations.
* Subjects able to read and understand Dutch language.

Exclusion Criteria:

* active Infection (or within 6 weeks after infection)
* Sepsis
* Osteomyelitis
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions
* diagnosed Osteoporosis or Osteomalacia
* Metabolic disorders which may impair bone formation
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease.

Primary outcomes:
measure: Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)
timeFrame: 2 years postoperatively
Secondary outcomes:
measure: Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty
timeFrame: 2 years postoperatively
measure: Early Survival Assessed by Counting the Number of Implant Revisions
timeFrame: Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively
measure: Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)
timeFrame: pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
measure: Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation
timeFrame: 6 weeks, 1 year and 2 years postoperatively
measure: Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 2 years postoperatively
measure: Clinical Performance Measured by Patient Based Outcome EQ5D
timeFrame: 2 years postoperatively
measure: Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)
timeFrame: pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively
measure: Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)
timeFrame: 6 weeks, 1 year and 2 years postoperatively
Other outcomes:
Locations:
city: Roosendaal
country: Netherlands
facility: Bravis
Study officials:
affiliation: Zimmer Biomet
name: Paola Vivoda, BSc
role: STUDY_DIRECTOR
References: