Comparison of Metal on Metal Total Hip Arthroplasty and Metal on Metal Total Hip Resurfacing.

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.

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

Study Overview

• Status: Completed
• Conditions: Arthroplasty; Hip; Replacement
• Intervention / Treatment: Device: THA; Device: HR

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LDH THA; large diameter head total hip arthroplasty	Device: THA; Three surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. For the THA, the standard techniques proposed by the manufacturer for insertion of the stem were followed. Neck sleeve adapters and three different prosthetic neck-shaft angles (125, 135, and 145) were available to adjust leg length and femoral offset with the large-diameter head THA system.
Active Comparator: HR; metal-on-metalhip resurfacing	Device: HR; Three surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. In the HR group, the capsulotomy was completed circumferentially, and the gluteus tendinous insertion on the femur was released in all men, but only when needed in women, to improve femur mobilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant revisions	Implant revisions rate will be compared between groups.	Preoperative to 15 years
Reasons of revisions	Reasons of revisions will be categorized and compared between groups.	Preoperative to 15 years
Adverse events	Adverse events will be categorized and compared between groups.	Preoperative to 15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome measures (PROMs) : Womac	Womac score will be compared between groupsScore and Patient's Joint Perception.	Preoperative to 15 years
Patient reported outcome measures (PROMs) : UCLA activity	The UCLA activity score will be compared between groups.	Preoperative to 15 years
Patient reported outcome measures (PROMs) : Forgotten Joint	Forgotten Joint score will be compared between groups.	Preoperative to 15 years
Whole blood chromium metal ions levels	Whole blood chromium metal ion measurements will be compared between groups for participants without other bodily metallic implants or revised implants.	Preoperative to 15 years
Whole blood cobalt metal ions levels	Whole blood cobalt metal ion measurements will be compared between groups for participants without other bodily metallic implants or revised implants.	Preoperative to 15 years
Radiological evaluation of femoral stem loosening	Signs of definite femoral stem loosening included continuous lucent lines > 2 mm, stem fracture, subsidence > 5 mm, or a change in component angulation >5° will be compared between groups.	Preoperative to 15 years
Radiological evaluation of acetabular loosening	Signs of definite acetabular loosening presented as continuous radiolucency > 2 mm, component migration > 3 mm or angulation change >5° will be compared between groups.	Preoperative to 15 years
Radiological evaluation of heterotopic ossification	Signs of heterotopic ossification grade, estimated according to the Brooker classification, will be compared between groups.	Preoperative to 15 years

Collaborators and Investigators

• Sponsor: Ciusss de L'Est de l'Île de Montréal

Publications and helpful links

General Publications

• 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.

Helpful Links

• The John Charnley Award: The functional outcome of hip resurfacing and large-head THA is the same: a randomized, double-blind study

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2005
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Metal-Metal; Large Diameter Head Total Hip Arthroplasty; Hip Resurfacing
• Other Study ID Numbers: 04132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No