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Selecting the Right Hip Prosthesis for Young Patients

Primary Purpose

Osteoarthritis, Hip

Status

Active

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Total Hip Arthroplasty

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Hip arthroplasty

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.).
Aseptic caput necrosis (posttraumatic, idiopathic).
Varus or valgus deformity in proximal femur (collum angle <125 ° or> 145 °.)
Collum femoris assessed too retro- or anteverted.

Sites / Locations

Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Primoris

Echo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Bone Mineral Density

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

Secondary Outcome Measures

Gait analysis

Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively.

Radio Stereometric Analysis (RSA)

Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes

European Quality of life in 5 Dimensions (EQ5D)

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Harris Hip Score (HHS)

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Oxford Hip Score (OHS),

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

University of California Los Angeles Activity Score (UCLA)

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Forgotten Joint Score (FJS)

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Full Information

NCT ID

NCT03279276

First Posted

August 31, 2017

Last Updated

April 7, 2022

Sponsor

Northern Orthopaedic Division, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT03279276

Brief Title

Selecting the Right Hip Prosthesis for Young Patients

Official Title

Selection of Hip Prosthesis for Younger Patients? Primoris® Short Femur Component vs. Echo® Standard Femur Component. Comparison of Bone Re-modeling, Prosthetic Migration and Gait Function. Controlled Randomized Study of 60 Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

December 10, 2019 (Actual)

Study Completion Date

December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northern Orthopaedic Division, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The overall purpose of this study is to show whether the Primoris® hip prosthesis results in a smaller loss of bone density than standard hip prosthesis, which in the longer term may result in an improved survival of prosthesis No. 2 after revision / replacement of a Primoris® hip prosthesis. The primary outcome is periprosthetic bone quality in Primoris® hip prosthesis compared to standard hip prosthesis measured by DXA scanning. The secondary outcomes are to assess: The hip function measured by gait analysis. Hip strength at pressure gauge. Prosthetic migration / migration measured by radio-stereometric analysis (RSA). Patient satisfaction measured by PROMs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Hip

Keywords

Hip arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Primoris

Arm Type

Experimental

Arm Description

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

Arm Title

Echo

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Total Hip Arthroplasty

Intervention Description

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.

Primary Outcome Measure Information:

Title

Bone Mineral Density

Description

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

Time Frame

2 -10 years

Secondary Outcome Measure Information:

Title

Gait analysis

Description

Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively.

Time Frame

1 year

Title

Radio Stereometric Analysis (RSA)

Description

Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes

Time Frame

2-10 years

Title

European Quality of life in 5 Dimensions (EQ5D)

Description

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Time Frame

2-10 years

Title

Harris Hip Score (HHS)

Description

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Time Frame

2-10 years

Title

Oxford Hip Score (OHS),

Description

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Time Frame

2-10 years

Title

University of California Los Angeles Activity Score (UCLA)

Description

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Time Frame

2-10 years

Title

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Description

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Time Frame

2-10 years

Title

Forgotten Joint Score (FJS)

Description

This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Time Frame

2-10 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.). Aseptic caput necrosis (posttraumatic, idiopathic). Varus or valgus deformity in proximal femur (collum angle <125 ° or> 145 °.) Collum femoris assessed too retro- or anteverted.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mogens Laursen, MD, PhD

Organizational Affiliation

Northern ODD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital

City

Farsø

State/Province

Northern Jutland

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

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Selecting the Right Hip Prosthesis for Young Patients

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