Selecting the Right Hip Prosthesis for Young Patients

NCT03279276 | Active Not Recruiting DMC

• 1 other identifier: N-20170030
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There have been no previously published clinical randomized studies comparing Primoris®, short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone density and function development. This is the subject for this study.

Conditions

Osteoarthritis, Hip

Keywords

Hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.

  2 -10 years

Secondary Outcomes (8)

• Gait analysis

  1 year

• Radio Stereometric Analysis (RSA)

  2-10 years

• European Quality of life in 5 Dimensions (EQ5D)

  2-10 years

• Harris Hip Score (HHS)

  2-10 years

• Oxford Hip Score (OHS),

  2-10 years

Study Arms (2)

Primoris

EXPERIMENTAL

Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®.

Procedure: Total Hip Arthroplasty

Echo

ACTIVE COMPARATOR

Total hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®.

Procedure: Total Hip Arthroplasty

Interventions

Total Hip Arthroplasty PROCEDURE

The usual procedures of the department: Moore incision and insertion of uncemented joints (exceed with vitamin E enriched polyethylene liner and 32 or 36 mm head). Cyclokaprone is administered peroperatively (bleeding-reducing), antibiotics and thrombosis prophylaxis. Follow the usual rehabilitation regimes, fast track, incl. Use of crutches and must support within the pain limit, possibly with crutches the first 4 weeks after surgery, then full load. By default, postoperative X-ray and RSA recordings will be performed on the 1st or 2nd postoperative day. The surgery will be performed by specialist physicians in orthopedic surgery associated with the hip arthroplasty sector.

Echo; Primoris

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women ≤ 45 years or men ≤ 55 years with hip osteoarthritis, suitable for hip prosthesis.
• Patients who wish to participate in the project and give written consent after oral and written information.

You may not qualify if:

• Patients with previous bone disease, metabolic disease, including diabetes, or the use of drugs that affect bone density.
• Smoking more than 20 cigarettes daily
• Patients with fracture in the femur or acetabulum.
• Patients who do not understand the given patient information
• Competing disorder requiring treatment with antiinflammatory drugs (NSAIDs, steroid, cytostatics).
• Estimated residual life \<10 years
• Rheumatoid arthritis or other arthritis (eg psoriasis arthritis).
• Previous surgery on the relevant hip joint.
• Co-Morbidity (ASA Group 3-5).
• Neurological disorder that compromises motor skills and rehabilitation.
• Pregnancy.
• Osteoarthritis secondary to mb. Calvé-Legg-Perthes / Avascular Caput Necrosis, Epiphysiolysis Capitis Femoris and Multiple Epiphysic Dysplasia.
• Acetabular dysplasia with secondary subluxation (Crowe grade II to IV).
• Previously detected osteoporosis or osteoporosis detected by current DXA scanning.
• Ongoing treatment with osteoporosis medicine (bisphosphonates, estrogen receptor modulators and parathyroid hormone, etc.).

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead

Study Sites (1)

Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Mogens Laursen, MD, PhD

  Northern ODD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 12, 2017
• Study Start: June 1, 2018
• Primary Completion: December 10, 2019
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)