Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures

NCT01578408 | Completed

• 1 other identifier: Corail-SP Study
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective randomized study is to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures. Our hypothesis is that an uncemented option spares the patient the operative load of the cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn also perhaps reduces the postoperative cognition strain and improves mobilization parameters. If the uncemented option has the same excellent fixation in poor bone stock, as in the case of these osteopenic fractures, and also has the same good clinical outcome, it would be a viable standard option for the treatment of dislocated femoral neck fractures.

Conditions

Femoral Neck Fractures

Keywords

Femoral neck fractures; Uncemented; Hydroxyapatite; Coated; Femoral; Stems; Hip fractures; THA; THR; Cemented; Fat embolism; Cognition; Inflammatory response; Mobilization

Outcome Measures

Primary Outcomes (1)

• Time to mobilization.

  Time (days) to mobilization defined as independent walking with or without walking aids measured by ward physiotherapist with Traffic Light System and Sahlgrenska University Hospital Hip Score (SUHS).

  During hospital stay, an expected average of 10 days.

Secondary Outcomes (7)

• Cognitive status. Eventual confusion.

  During hospital stay, an expected average of 10 days.

• Oxygen saturation levels peroperatively.

  Peroperatively (during surgery), an expected average of 2 hours.

• Bone remodeling around the hip prosthesis.

  Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.

• Biomarkers / inflammatory response.

  Preoperatively in average 4 hours. Peroperatively at end of wound closure. Postoperatively 1, 3, 5, 7 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.

• Fixation / migration / loosening of the hip prosthesis components.

  Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years.

Study Arms (2)

Uncemented HA Coated Corail stem

ACTIVE COMPARATOR

Surgery with an inversed hybrid arthroplasty with an uncemented hydroxyapatite coated Corail stem and a cemented Marathon cup (DePuy).

Procedure: Total Hip Arthroplasty; Device: Uncemented HA Coated Corail stem

Cemented Lubinus SPII stem (control arm)

ACTIVE COMPARATOR

Surgery with a totally cemented option with a Lubinus SPII stem and a IP cup (Link).

Procedure: Total Hip Arthroplasty; Device: Cemented Lubinus SPII stem (control arm)

Interventions

Total Hip Arthroplasty PROCEDURE

Cemented Lubinus SPII stem (control arm); Uncemented HA Coated Corail stem

Cemented Lubinus SPII stem (control arm) DEVICE

Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link).

Cemented Lubinus SPII stem (control arm)

Uncemented HA Coated Corail stem DEVICE

Uncemented hydroxyapatite coated Corail femoral stem. Cemented Marathon acetabular cup. (DePuy).

Uncemented HA Coated Corail stem

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are acutely admitted to hospital with dislocated femoral neck fractures, that in clinical praxis are in the need of hip prosthesis surgery, are recruited in the study. The fracture shall not engage the lesser nor the greater trochanters.
• Patients who wants to participate in the study and who can consider participation for at least 1 year.
• Coming from independent dwelling conditions.
• Not dementia.
• Circa 60-85 years of age.
• Circa 50 patients in each arm/group shall be included at Mölndal's Hospital (part of Sahlgrenska University Hospital).

You may not qualify if:

• Patients who have difficulties in understanding the intent of the study.
• Rheumatic disorders (RA, Bechterew, SLE).
• Cortison treatment.
• Stroke with remaining weakness or neurological disorders with affection of locomotion.
• Dementia.
• Grave obesity with BMI \>=30-35.
• Delay between time of injury and time of surgery exceeding 72 hours.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• DePuy Orthopaedics: collaborator

Study Sites (1)

Mölndals Hospital (part of Sahlgrenska University Hospital)

Mölndal, 43180, Sweden

Location

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures; Embolism, Fat

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Johan Kärrholm, Prof MD PhD

  Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, SWEDEN

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician in Orthopaedic Surgery

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 17, 2012
• Study Start: May 11, 2010
• Primary Completion: March 9, 2018
• Study Completion: February 19, 2020
• Last Updated: September 24, 2020

Record last verified: 2020-09

Locations

SE (1)