Clinical trial NCT04516239: Comparison of Metal on Metal Total Hip Arthroplasty and Metal on Metal Total Hip Resurfacing.
Official title: Prospective Double-blind Randomized Clinical Trial Comparing Gait Analysis and Clinical Function After Metal on Metal Total Hip Arthroplasty With Large Diameter Femoral Head and Metal on Metal Total Hip Resurfacing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroplasty
Replacement
Hip
Keywords: Metal-Metal
Large Diameter Head Total Hip Arthroplasty
Hip Resurfacing
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a prospective randomized clinical trial with two parallel treatment groups. At the preoperative teaching session, the study objectives and the risks and benefits of surgery will be explained to the patient by the research assistant or the surgeon in order to obtain consent. A randomization table will be generated by the SPSS 10 software and sealed numerated envelopes will be assigned to each patient entering the study. A research assistant will coordinate the study and data collection.
Primary purpose: TREATMENT

Brief summary: The goal of this double-blind prospective randomized study is to compare subjective outcome measures and gait parameters between conventional THA using large diameter femoral heads and total hip resurfacing

Detailed description: In the early 1960's Sir John Charnley revolutionized total hip arthroplasty (THA) with the introduction of polyethylene as a bearing surface. This innovation allowed THA to become a very successful procedure to treat degeneration of the hip joint, with excellent long term clinical outcome and patient satisfaction.

However, this technique requires sacrifice of the whole femoral head and part of the neck. This bone will not be available for future revision surgery, which seems inevitable in the younger patient. THA does not always allow precise reconstitution of normal hip biomechanics. The femoral canal is also violated, fat and cement embolism can occur and thrombogenic material is released in the bloodstream. Postoperatively the femoral stem can cause thigh pain, proximal stress shielding, and periprosthetic fracture may occur . Finally the use of a 28 millimeter non anatomic femoral head during conventional THA increases the risk of hip impingement and dislocation while limiting hip range of motion.

There is renewed interest in the concept of hip resurfacing and the use of large diameter femoral heads in total hip arthroplasty, since both these options recreate more optimal hip biomechanics. Total hip resurfacing is less invasive than conventional THA using a femoral stem and allows restoration of normal hip anatomy. Additionally, compared to conventional THA, hip resurfacing has the following advantages: preservation of the femoral head and neck, better hip stability, improved hip biomechanics (leg length, offset) and possibly better proprioception. Since the femoral canal is not violated, there is less risk of residual thigh pain, and patients probably have the sensation of a more normal feeling joint.

As for conventional THA with large diameter femoral heads, the use of a near anatomic head size (compared to the small 28mm diameter head use with conventional THA) restores normal stability, helps reduce the incidence of impingement and increases range of motion to a greater extent than hip resurfacing, and might improve proprioception as well. The investigators believe these advantages will have a positive influence on clinical function and gait pattern compared to conventional THA.

Gait analysis has demonstrated that gait pattern is modified after THA and patients do not recover normal gait. Kinematics analysis further showed that abnormal gait pattern is not only observed in the operated hip but also in other articulations, including the contra lateral limb. Walking kinetics are affected to some extent, especially the force generated by the lower limb and synchronization of muscle activity. Finally a subjective feeling of an abnormal hip function may still persists after THA.

The goal of this double-blind prospective randomized study is to compare subjective outcome measures and gait parameters between conventional THA using large diameter femoral heads and total hip resurfacing

Eligibility criteria: Inclusion Criteria:

1. Patient with degenerative disease of the hip in need for total hip or total hip resurfacing arthroplasty
2. Patient who understands the study protocol and willing to comply with the planned clinical follow-up
3. Patient can give informed consent

Exclusion Criteria:

1. Age older than 65 years old or younger than 18 years old
2. Charnley class B (both hip diseased) or C (polyarticular disease) patients
3. Spinal or lower limb disease other than the degenerated hip that could influence gait and walking performance
4. Neuromuscular disorder
5. Known or suspected metal allergy
6. Pregnancy
7. Renal insufficiency
8. Known or suspected osteopenia or osteoporosis of the hip

Primary outcomes:
measure: Implant revisions
timeFrame: Preoperative to 15 years
measure: Reasons of revisions
timeFrame: Preoperative to 15 years
measure: Adverse events
timeFrame: Preoperative to 15 years
Secondary outcomes:
measure: Patient reported outcome measures (PROMs) : Womac
timeFrame: Preoperative to 15 years
measure: Patient reported outcome measures (PROMs) : UCLA activity
timeFrame: Preoperative to 15 years
measure: Patient reported outcome measures (PROMs) : Forgotten Joint
timeFrame: Preoperative to 15 years
measure: Whole blood chromium metal ions levels
timeFrame: Preoperative to 15 years
measure: Whole blood cobalt metal ions levels
timeFrame: Preoperative to 15 years
measure: Radiological evaluation of femoral stem loosening
timeFrame: Preoperative to 15 years
measure: Radiological evaluation of acetabular loosening
timeFrame: Preoperative to 15 years
measure: Radiological evaluation of heterotopic ossification
timeFrame: Preoperative to 15 years
Other outcomes:
Locations:
Study officials:
References:
citation: Kostretzis L, Lavigne M, Kiss MO, Shahin M, Barry J, Vendittoli PA. Despite higher revision rate, MoM large-head THA offers better clinical scores than HR: 14-year results from a randomized controlled trial involving 48 patients. BMC Musculoskelet Disord. 2021 Apr 30;22(1):400. doi: 10.1186/s12891-021-04286-6.