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

NCT04516239 | Completed Phase 4

• 1 other identifier: 04132
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Conditions

Arthroplasty; Replacement; Hip

Keywords

Metal-Metal; Large Diameter Head Total Hip Arthroplasty; Hip Resurfacing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Patient reported outcome measures (PROMs) : Womac

  Preoperative to 15 years

• Patient reported outcome measures (PROMs) : UCLA activity

  Preoperative to 15 years

• Patient reported outcome measures (PROMs) : Forgotten Joint

  Preoperative to 15 years

• Whole blood chromium metal ions levels

  Preoperative to 15 years

• Whole blood cobalt metal ions levels

  Preoperative to 15 years

Study Arms (2)

LDH THA

ACTIVE COMPARATOR

large diameter head total hip arthroplasty

Device: THA

HR

ACTIVE COMPARATOR

metal-on-metalhip resurfacing

Device: HR

Interventions

THA DEVICE

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.

LDH THA

HR DEVICE

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.

HR

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 33941155 DERIVED

Related Links

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be informed of the randomization group, 6 months after surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedist

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 18, 2020
• Study Start: September 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: July 1, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share