Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in combination with the optimys short stem. Wear rate and migration is assessed with roentgen stereophotogrammetric analysis (RSA) measurements.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty

NCT04618016

Osteoarthritis, Knee Arthritis, Rheumatoid Intra-Articular Fractures +2 more

ACTIVE_NOT_RECRUITING

A Multi-Site Evaluation of the Pain Relief, Support, Fit and Comfort From Use of a Custom Knee or Ankle Brace in Persons Suffering From Chronic Ankle or Knee Pain and Instability

NCT02682654

Joint Instability

COMPLETED NA

Combined Prospective and Retrospective Post-Market Follow Up of the 'BPK-S Integration' UC as Primary Implant in the Variant CoCr

NCT03406637

Osteoarthritis, Knee Joint Instability

COMPLETED

A Novel Shape Memory Alloy-Based Orthosis for Proximal Interphalangeal Joint Stiffness

NCT06716086

Finger Proximal Interphalangeal Joint Contracture

RECRUITING NA

Knee Bracing for People With Patellofemoral Osteoarthritis

NCT00381563

Knee Osteoarthritis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Joint Arthritis, Degenerative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomised single-center study with 2 treatment arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

seleXys PC

seleXys PC cup combined with the optimys stem

Group Type EXPERIMENTAL

seleXys PC

Intervention Type DEVICE

Total hip arthroplasty using the seleXys PC cup

RM

RM Pressfit vitamys cup combined with the optimys stem

Group Type ACTIVE_COMPARATOR

RM

Intervention Type DEVICE

Total hip arthroplasty using the RM cup

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

seleXys PC

Total hip arthroplasty using the seleXys PC cup

Intervention Type DEVICE

RM

Total hip arthroplasty using the RM cup

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with symptomatic arthritis who are candidates for a primary total hip arthroplasty with an uncemented femoral stem as determined jointly by the surgeon and the patient.
* Patients suitable for an uncemented acetabular component in combination with a 36mm femoral head (seleXys PC cup: 52mm, 54mm or 56mm; RM Pressfit vitamys: 52mm, 54mm or 56mm)
* Patients between the ages of 50 and 75 inclusive
* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion Criteria

* Patients that require an acetabular cup size which cannot be used in combination with a 36mm femoral head
* Patients that offer no guarantee for regular follow-up controls
* Patients that have a revision surgery
* Patients that have a fracture of the femoral neck or a bone tumour in the area of the femur or pelvis
* Patients that had a previous osteotomy of the femur or pelvis
* Pregnant women or those seeking to become pregnant
* Patients with a history of active infection

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No