Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02247791
Other study ID # CHANCE
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 21, 2013
Last updated January 27, 2016
Start date September 2009
Est. completion date September 2024

Study information

Verified date January 2016
Source Danderyd Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.


Description:

The study will randomize patients between an uncemented and cemented stem


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date September 2024
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 65 Years to 79 Years
Eligibility Inclusion Criteria:

- Acute Displaced femoral neck fracture

- Subject is aged between 65-79 years

- Independent walker with or without walking aides

- Subject is able and capable of providing consent to participate in the study

Exclusion Criteria:

- Patients with Rheumatoid Arthritis

- Patients with an impaired cognitive dysfunction

- Patients with Pathological fractures

- Patients with substance abuse

- Patients with fracture older than 36-hours on arrival at the A&E

- Patients suffering from cancer

- Patients determined by principal investigator to be unsuitable for inclusion

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Uncemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
Cemented femoral stem
All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem

Locations

Country Name City State
Sweden Danderyd Hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Danderyd Hospital Biomet, Inc.

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hip related complication rate All hip-related complications 2 years Yes
Primary Health-related Quality of Life Health related quality of life 2 years No
Secondary Duration of surgery 2 years Yes
Secondary Intraoperative bleeding 2 years Yes
Secondary Hip function Measured with Harris hip score 2 years No
See also
  Status Clinical Trial Phase
Completed NCT02507609 - Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium N/A
Completed NCT03906864 - Care Pathway for Sub-acute Hip Rehabilitation N/A
Recruiting NCT04063891 - Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients N/A
Completed NCT05039879 - Life Improving Factors After a Hip Fracture
Not yet recruiting NCT03887494 - Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY) N/A
Terminated NCT03065101 - Trigen InterTAN vs Sliding Hip Screw RCT N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Completed NCT03545347 - Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture. Phase 2
Recruiting NCT05971173 - Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery Early Phase 1
Active, not recruiting NCT04957251 - Anterior vs Posterior Approach for Hip Hemiarthroplasty N/A
Terminated NCT04372966 - Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures N/A
Withdrawn NCT05030688 - Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty N/A
Completed NCT04424186 - 'Rehabilitation for Life' N/A
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Withdrawn NCT05518279 - Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures Phase 3
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Completed NCT00746876 - Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. N/A
Completed NCT00058864 - The HIP Impact Protection Program (HIP PRO) N/A
Completed NCT05549011 - PENG vs SIFI Block for Positioning Pain During Spinal Anesthesia