Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

Not Applicable

Completed

Conditions: Hip Osteoarthritis
Noninflammatory Degenerative Joint Disease
Correction of Functional Deformity
Rheumatoid Arthritis
Avascular Necrosis

Interventions: Device: Taperloc Complete Reduced Distal stem
Device: Taperloc Complete Microplasty stem

Registration Number: NCT03409666

Lead Sponsor: Zimmer Biomet

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taperloc Complete Reduced Distal stem	Taperloc Complete Reduced Distal stem	Subjects in need of a total hip arthroplasty who received the Taperloc Complete Reduced Distal stem.
Taperloc Complete Microplasty stem	Taperloc Complete Microplasty stem	Subjects in need of a total hip artthroplasty who received the Taperloc Complete Microplasty stem.

Primary Outcome Measures

Name	Time	Method
Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)	2 years postoperatively	Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)

Secondary Outcome Measures

Name	Time	Method
Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)	6 weeks, 1 year and 2 years postoperatively	The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis. The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.
Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)	pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively	Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)
Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)	2 years postoperatively	The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.
Clinical Performance Measured by Patient Based Outcome EQ5D	2 years postoperatively	Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).
Early Survival Assessed by Counting the Number of Implant Revisions	Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively	Assessed by counting the number of implant revisions
Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation	6 weeks, 1 year and 2 years postoperatively	Assess radiographs for signs of stress shielding, radiolucency and stem alignment.
Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty	2 years postoperatively	Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.
Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)	pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively	The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.