Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old

NCT ID: NCT02338596

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2014-03-31

Brief Summary

As clinical and radiographic performance of an ultra-short anatomic cementless stem have been investigated only two randomized controlled studies, well-designed trials should aim for a thorough comparison of the outcomes of ultra-short and conventional cementless stems. The purpose of this study was to compare the outcomes of ultra-short and conventional stems in the same young patients who underwent simultaneous bilateral sequential total hip arthroplasties.

Detailed Description

Conventional cementless femoral stems are known to provide a high rate of satisfactory clinical outcomes at long-term follow-ups. However, they may have potential clinical consequences related to stress shielding, thigh pain, periprosthetic fractures, proximal/distal dimensional mismatch, an easier access pathway for wear debries and removal during revision. In an effort to reduce the risk of stress shielding, thigh pain, periprosthetic fracture, proximal/distal stem mismatch, and to facilitate removal of well fixed stem, a new ultra-short anatomic metaphyseal-fitting cementless femoral stem was developed. It was designed to provide closely mimicking the original functioning hip. The absence of the diaphyseal anchorage attempt proximal load transfer to reduce stress shielding, thigh pain and proximal distal/mismatch. Furthermore, it attempts to preservation of the femoral canal and femoral elasticity and ease of revision. The question thus arises whether it is possible to obtain strong and long-lasting fixation of the femoral component without diaphyseal anchoring.

As clinical and radiographic performances of this ultra-short stem have been investigated only in a few studies and at short-term follow-ups, it remains to be elucidated whether an ultra-short stem shows a low incidence of implant loosening, stem misalignment, intraoperative fractures and revision rate. The purpose of this randomized controlled study to compare: (1) the clinical results, including Harris hip score, thigh pain, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index score, and patients' satisfaction; (2) radiographic results, including stress shielding, implant loosening, stem misalignment; and (3) intraoperative fractures and revision rates of cementless total hip arthroplasty using an ultra-short anatomic metaphyseal-fitting cementless femoral stem versus a conventional metaphyseal and diaphyseal fitting anatomi proximal porous-coated cementless stem in the same patients who underwent bilateral simultaneous sequential total hip arthroplasty under one anesthetic.

Conditions

Hip Replacement, Total; Osteonecrosis of Femoral Head; Coxarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional stem

total hip replacement operated with conventional stem (Profile; DePuy, Leeds, United Kingdom)

Group Type: EXPERIMENTAL

Total hip replacement

Intervention Type: PROCEDURE

1. Simultaneous bilateral sequential total hip arthroplasties under the same anesthetic.

2. Randomization to treatment with an ultra-short or a convnetional cementless stem was accomplished with use of study numbers in sealed envelope, which were opened in the operating room before the skin incision was made.

3. The pore size was 250㎛. A 28-mm-diameter Biolox forte ceramic femoral head (CeramTec AG, Polchingen, Germany) ) was used in all hips. A cementless cup and a 28mm internal-diameter Biolox forte ceramic liner was used in all hips in both groups.

Ultra-Short stem

total hip replacement operated with ultra-short stem (Proxima; DePuy, Leeds, United Kingdom)

Group Type: ACTIVE_COMPARATOR

Total hip replacement

Intervention Type: PROCEDURE

1. Simultaneous bilateral sequential total hip arthroplasties under the same anesthetic.

2. Randomization to treatment with an ultra-short or a convnetional cementless stem was accomplished with use of study numbers in sealed envelope, which were opened in the operating room before the skin incision was made.

3. The pore size was 250㎛. A 28-mm-diameter Biolox forte ceramic femoral head (CeramTec AG, Polchingen, Germany) ) was used in all hips. A cementless cup and a 28mm internal-diameter Biolox forte ceramic liner was used in all hips in both groups.

Interventions

Total hip replacement

1. Simultaneous bilateral sequential total hip arthroplasties under the same anesthetic.

2. Randomization to treatment with an ultra-short or a convnetional cementless stem was accomplished with use of study numbers in sealed envelope, which were opened in the operating room before the skin incision was made.

3. The pore size was 250㎛. A 28-mm-diameter Biolox forte ceramic femoral head (CeramTec AG, Polchingen, Germany) ) was used in all hips. A cementless cup and a 28mm internal-diameter Biolox forte ceramic liner was used in all hips in both groups.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• End stage hip arthritis

Exclusion Criteria

• Age above 50 years old
• Inflammatory arthritis
• Coexisting foot or ankle disorder limiting walking

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ewha Womans University

OTHER

Sponsor Role: lead

Responsible Party

Young Hoo Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young-Hoo Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor

Other Identifiers

Shortstem005

Identifier Type: -

Identifier Source: org_study_id