Fitmore Versus CLS Stem in Total Hip Arthroplasty. Bilateral One-stage Operations

NCT03112785 | Active Not Recruiting DMC

• 1 other identifier: Fitmore2011
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Main question: Will use of a stem design that allows anatomical reconstruction of the hip joint improve the outcome in terms of hip function and patient satisfaction without causing any adverse effects? Background: Total hip arthroplasty with use of the most well documented implants is a safe and cost-effective procedure. In the Swedish Hip Arthroplasty register the CLS stem has a 16 years implant survival of 97, 5 %. It is a classic design which requires resection of most of the neck. The stem also intrudes into the greater trochanter which in patients with certain types of proximal hip anatomy makes proper introduction of the stem difficult. Finally it has a standard stem length which will jeopardise future stem removal should there occur any late infection or instability problems. Short uncemented stems have been introduced to enable a more anatomic reconstruction of the hip joint and to cause less invasion of the femoral canal to facilitate future revision should it be necessary. A more conservative resection of neck could also be of value to improve the clinical outcome by improved hip function and patient satisfaction. Purpose of the present study and design: In a prospective study the clinical outcome, stem fixation and bone remodelling around a short stem (Fitmore) will be studied. The main focus will be to evaluate patient reported outcomes especially concerning function, over all satisfaction, pain and activity. All patients will receive the same cup (Trilogy). This cup is chosen because it has a very thorough documentation in prospective RSA studies and in the Swedish hip arthroplasty register. All cups will be supplied with insert made of high molecular polyethylene (Longevity). Number of hips in the study: 44 consecutive cases

Conditions

Primary Hip Osteoarthritis; Secondary Hip Osteoarthritis Due to Idiopathic Femoral Head Necrosis, Childhood or Inflammatory Disease; Bilateral Hip Disease; Surgical Treatment

Keywords

Hip; Arthroplasty; Stem; Outcome

Outcome Measures

Primary Outcomes (1)

• Preferred hip (the hip arthroplasty preferred by the patient, right or left side)

  Study specific protocol in which the patient from a general view tics one of 3 options: left side, right side or no difference). In the term preferred view the patient is asked to consider all aspects they Think are important such as freedom from pain, mobility, function or any other type of discomfort.

  2 years

Secondary Outcomes (3)

• Stem subsidence (distal migration of the stem)

  2 years

• Extent of radiolucent lines around the stem

  2 years

• Any new surgical procedure where the stem is removed or Exchanges (revision of the stem)

  2, 5 and 10 years

Interventions

Total hip arthroplasty (Fitmore or CLS uncemented femoral stem made by Zimmer-Biomet, Warshaw, USA) DEVICE

The most symptomatic side is randomised to one of the two stem types studied. If the patient has equal amount of symptoms on both sides, the one with most pronounced degenerative Changes on plain radiographs will be randomised. On the second side the type of stem not used on the first one will be inserted. All patients and allhip will receive the same type and design of cup.

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hip anatomy suitable for the Fitmore stem according to preoperative planning
• Males and females aged 35 to 75 years (with bilateral hip disease).
• Primary osteoarthritis.
• Secondary osteoarthritis due to idiopathic femoral head necrosis, childhood or inflammatory disease. -

You may not qualify if:

• Treatment with Cortisol or known osteoporosis.
• Low expected activity rate due to other diseases including any generalized joint disease.
• Anatomy unsuitable for the Fitmore stem.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Zimmer Biomet: collaborator

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

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

Study Officials

• Johan N Kärrholm, MD, Professor

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

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: MD Professor in Orhopaedics

Model Details: Patients with bilateral degenerative hip osteoarthritis are operated with a short stem total hip arthroplasty on one side and a conventional stem on the opposite side. Implant selection is randomised on the most symptomatic side, the second side receives the type of stem not used on the first one.

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 13, 2017
• Study Start: March 17, 2011
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share