Five-year Migration Pattern and Bone Mineral Density for the Tri-Lock and Summit Femoral Stems.

NCT06019026 | Completed

• 1 other identifier: Tri-Lock vs. Summit
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The incidence of primary hip joint prosthesis is 180 per. 100,000 inhabitants. In male patients younger than 50 years the 10-years survival of the prosthesis is 89 % and 82 % over 15 years. In women younger than 50 years the 10-years survival of the prosthesis is 87 % and 78 % over 15 years. As revision surgery is associated with higher complication risk for the patient and poorer out-come and implant survival it is necessary to examine possible methods that may increase long-term survival of the primary hip prosthesis or facilitate better outcomes after revision of hip joint prostheses for younger patients. In younger patients the prosthesis often is inserted without the use of cement. When not using cement, it is crucial for the final result, that there is a direct bone ingrowth of the prosthesis. The chance of getting bone ingrowth depends firstly on a good immediate mechanical fixation at surgery and secondly on osteoconductive abilities of the prosthetic surface. This study investigates a new bone sparing implant with a new surface compared to a conventional implant.

Conditions

THA

Keywords

THA; Hip; RSA; Cementless; Radiostereometric analysis

Outcome Measures

Primary Outcomes (2)

• Migration (3D rotation and translation) Measured with radiostereometric analysis (RSA)

  Subsidence (distal translation mm) and retroversion (negative vertical rotation deg.)

  5 years

• Bone mineral density (BMD) measured with dual-energy x-ray absorptiometry

  By Gruen zones, calculated as changes from baseline recording.

  5 years

Secondary Outcomes (3)

• Health related quality of life measured with EuroQol-5 Domain (EQ5D)

  5 years

• Patient perceived hip function measured with Oxford hip score (OHS)

  5 years

• Pain measured on a visual analog scale (VAS)

  5 years

Study Arms (2)

Tri-Lock

EXPERIMENTAL

Total hip arthroplasty performed through posterolateral access using the uncemented Tri-Lock short stem.

Device: Tri-Lock

Summit

ACTIVE COMPARATOR

Total hip arthroplasty performed through posterolateral access using the uncemented Summit standard stem.

Device: Summit

Interventions

Tri-Lock DEVICE

Implant Stem

Tri-Lock

Summit DEVICE

Implant Stem

Summit

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary hip osteoarthritis
• Patients with adequate bone stock for insertion of uncemented components(no osteoporosis as assessed by pre-operative dual-energy x-ray absorptiometry (DXA) scans)
• Informed, written consent

You may not qualify if:

• Patients with neuromuscular or vascular diseases in the affected leg
• Patients intraoperatively found unfit to uncemented components
• Patients who can not refrain from the use of non-steroidal anti-inflammatory drugs (NSAIDs) in post-operative recovery
• Patients with pre-operative fracture sequelae
• Women who are, or have a wish for pregnancy during the study period.
• Hip dysplasia or sequelae to Calves Perthes.

Sponsors & Collaborators

• Regional Hospital Holstebro: lead

Study Officials

• Torben Bæk Hansen, MD, PhD

  Gødstrup Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD PhD

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: August 31, 2023
• Study Start: January 1, 2015
• Primary Completion: August 31, 2017
• Study Completion: June 10, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share