Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures

NCT04372966 | Terminated DMC

• 1 other identifier: 06/S0501/80
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Displaced subcapital hip fractures are very common and account for almost 50% of all hip fractures. The aim of the present study is to determine whether an uncemented total hip replacement is better than conventional cemented hip replacement to treat these fractures.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Hip specific function

  This was measured using the Oxford hip score which ranges from 0 (worst score) to 48 (best score) points.

  1 year

Secondary Outcomes (10)

• Hip specific function

  6 and 72 months

• Hip specific function

  6, 12 and 72 months

• Generic health

  6, 12 and 72 months

• Mobility

  6 months

• Subjective patient hip pain

  6, 12 and 72 months

Study Arms (2)

Cemented

ACTIVE COMPARATOR

This group will receive a cemented Exeter stem and contemporary acetabular component (Stryker).

Device: Total hip arthroplasty

Uncemented

ACTIVE COMPARATOR

This group will receive an uncemented Corail stem and uncemented acetabular component (Depuy).

Device: Total hip arthroplasty

Interventions

Total hip arthroplasty DEVICE

Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.

Also known as: Total hip replacement

Cemented; Uncemented

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over the age of 60 years with a displaced intracapsular hip fracture and are admitted to the study centre and are under the care of four orthopaedic trauma surgeons
• patients who were independently mobile before their hip fracture
• patients without cognitive impairment (mini-mental score \>6) and able to give informed consent
• patients without serious concomitant disease

You may not qualify if:

• patients who are not independently mobile outside the home
• unable to give informed consent
• serious concomitant disease with anaesthetic risk too great for Tsurgery

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

NHS Lothian

Edinburgh, Edinburgh City, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomaised controlled trial

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 4, 2020
• Study Start: September 24, 2009
• Primary Completion: December 29, 2011
• Study Completion: December 29, 2016
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)