10 Year Clinical Evaluation of Primoris Hip Component

NCT01326832 | Active Not Recruiting

• 1 other identifier: BMETEU.CR.UK4A
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

Using the traditional and hitherto used uncemented hip prostheses achieved good clinical results, but one of the drawbacks is the risk of fracture in the femoral shaft in indbankning of the prosthesis (1-2%). In addition, the bone scan demonstrated that in the years after surgery dropped almost 30% of bone mass in the femoral shaft. This bone loss increases the risk that in the years after surgery, the increased risk of fractures around the prosthesis and in addition to impeding the described bone replacement prosthesis later. The newly developed prosthesis is anchored in the femoral neck and thus not involve the femoral shaft. This ensures a more physiological or normal weight transfer to the femur bone. This contributes to bone mass in long large extent preserved in the years after surgery, so you have a better opportunity later to make a new prosthesis surgery with good results. The new prosthesis should be capable of simultaneously reducing the incidence of thigh pain in the first year after surgery.'

Conditions

Coxarthrosis

Keywords

THA

Outcome Measures

Primary Outcomes (1)

• RSA

  radio stereographic analysis for prosthesis migration

  2 years

Secondary Outcomes (2)

• Harris Hip score

  10 years

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  10 years

Study Arms (1)

Primoris

50 patients included in RSA cohort of total of 350 anticipated Primoris cases

Device: Primoris

Interventions

Primoris DEVICE

Total hip arthroplasty with the new Primoris femoral component

Primoris

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

younger patients with coxarthrosis

You may qualify if:

• younger OA patients with good bonestock

You may not qualify if:

• Patients who do not understand the given information to patients
• Competing disorder requiring treatment with anti-inflammatory drugs (NSAIDs, steroids, cytostatics).
• Estimated remaining life expectancy \< 10 years
• Rheumatoid arthritis or other arthritis (eg psoriatic arthritis).
• Previous surgery on relevant hip.
• Pain Normative and disabling osteoarthritis of the ipsilateral knee.
• Co-mobiditet (ASA-group 3-5).
• Neurological disorder which compromises the motor skills and rehabilitation courses.
• Pregnancy.
• Osteoarthritis secondary to Calvé-Legg-Perthes' disease and juvenile epifysiolysis coxae.
• Acetabular dysplasia and secondary subluxation (Crowie grade II to IV).
• Previously established osteoporosis or osteoporosis detected by current DEXA scan.
• Ongoing treatment with osteoporosis medications (calcium and vitamin D, bisphosphonates, estrogen receptor modulating agents and parathyroid hormone, etc.).
• Aseptic caputnekrosis (post-traumatic, idiopathic).
• Deform the femoral neck (femoral length, measured medially ≤ 15 mm)

Sponsors & Collaborators

• Zimmer Biomet: lead
• Biomet Denmark A/S: collaborator

Study Sites (2)

Aalborg University Hospital

Aalborg, Denmark

Location

Veijle Hospital

Vejle, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Poul T NIELSEN, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: March 31, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

DK (2)