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Clinical Trials in Sweden / NCT05773261
Active, not recruiting Not applicable

Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups

NCT05773261 · tracked via the Priya Life Science Sweden tracker
Sponsor
Umeå University
Phase
Not applicable
Started
2022-09-09
Last updated
2023-12-08

Condition(s) studied

Osteoarthritis, Hip

Investigational drug(s) / intervention(s)

MobilLINK TrabecuLINK cupPinnacle Gription cup

MobilLINK TrabecuLINK cup: THA with MobilLINK TrabecuLINK cup and LCU stem

Pinnacle Gription cup: THA with Pinnacle Gription cup and Coral stem

Study summary

A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.

Eligibility

Sex
ALL
Min age
30 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patients are foreseen for implantation of an uncemented acetabular press-fit cup and an uncemented stem * Age 30-70 years * Primary osteoarthritis of the hip * Body Mass Index between 18 and 35 kg/m2 * Willingness and ability to follow clinical investigation protocol Exclusion Criteria: * Grossly abnormal hip anatomy (hip dysplasia, Crowe Grade 2 or above, Perthes or other causes) * Osteoporosis * Paget's disease * Inflammatory arthritis * Secondary osteoarthritis * Presence of malignancy in the area of surgery * Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months or less prior to surgery * Previous surgery in the affected hip * Inclusion of the contralateral hip in this clinical investigation * Not suited for the clinical investigation for other reason (surgeon's judgment) * Pregnant or breastfeeding women * Prison inmate

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Volker Otten Umeå Västerbotten County

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Other trials for the same condition

A Comparative Study of Stem and Cup Fixation and Polyethylene Wear Active, not recruiting
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. Recruiting
Digitalization of Osteoarthritis Care Active, not recruiting
Promoting Sleep to Alleviate Pain - Arthroplasty Recruiting
Avenir Complete Post-Market Clinical Follow-Up Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05773261 on ClinicalTrials.gov ↗ ← All trials in Sweden