| Methods | RCT Group A: Trapeziectomy alone Group B: Trapeziectomy with Interpositional Arthroplast (Palmaris Longus) Group C: Trapeziectomy with LRTI (FCR) |
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| Participants | Age (median): A/B/C = 57/57/57 Gender (female:male): A/B/C = 53:0/46:0/54:0 Stage of OA (mean): A/B/C = 3.5/3.6/3.7 |
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| Interventions | Surgery: Group A: Trapeziectomy using a dorsal approach. Percuatenous K‐wire was inserted through base of thumb metacarpal and passed longitudinally across the trapezial void into the distal scaphoid. THe K‐wire was removed at 4 weeks. A Plaster of Paris splint maintained the thumb in abduction with wrist in neutral for 6 weeks. At 6 weeks the patient started hand therapy to mobilise and strengthen the thumb. Group B: Trapeziectomy with interposition of palmaris longus tendon, sutured into a ball before placement into trapezial void. Postoperative thumb and wrist supported in Plaster of Paris splint with wrist in neutral and thumb in abduction. Kirschner wire through base of thumb metacarpal into distal pole of scaphoid for 4 weeks. Exercises to mobilise and strengthen thumb shown at 6 weeks when splint discarded. Group C: Trapeziectomy with LRTI (using FCR). Same technique as Burton 1986. Percuatenous K‐wire was inserted through base of thumb metacarpal and passed longitudinally across the trapezial void into the distal scaphoid. THe K‐wire was removed at 4 weeks. A Plaster of Paris splint maintained the thumb in abduction with wrist in neutral for 6 weeks. At 6 weeks the patient started hand therapy to mobilise and strengthen the thumb. |
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| Outcomes | Pain: The number of subjects who reported 'no pain or restrictions; discomfort with use, but no restrictions; pain with use, some restrictions; rest pain, no restrictions; rest pain, some restrictions; rest pain, severe restrictions; night pain' were recorded for each group. Physical function: Not reported. Patient global assessment: Not reported. Range of motion: Thumb opposition and thumb metacarpophalangeal hyperextension. Strength: Grip strength was measured with the Jamar dynamometer, and tip and key (lateral) pinch were measured with a Jamar pinch‐meter and measured in kg. Trapeziometacarpal joint imaging: No postoperative imaging was performed. Adverse events at 1 year and 5 years or more: nerve dysfunction (superficial radial nerve or palmar cutaneous branch of median), FCR/pollicis longus pulling sensation, tender scar, CRPS. |
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| Notes | We contacted one of the trial authors for further information who confirmed that same patient cohort as Davis 1997 and Davis 2004 published studies. One review author (TV) converted median and IQR to mean and SD values. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomisation occurred at induction of anaesthesia...stratified so 3 of each operation was conducted for each set of 9 consecutive surgeries." |
| Allocation concealment (selection bias) | Low risk | Quote: "randomisation was achieved by opening the next sequentially sealed opaque envelope that contained instructions as to which operation should be performed" Comment: Patient and surgeon adequately blinded from which procedure was to be performed until time of incision. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Unclear if participants or assessors were informed of surgery performed prior to final review. |
| Blinding of outcome assessment (detection bias) Subjective outcomes (patient reported) | Unclear risk | Comment: Unclear if participants were informed of surgery performed prior to final review. |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Comment: Two independent observers who were not involved in the surgical procedure carried out all assessments at final follow‐up. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "of the 174 operated thumbs...153 were assessed at a median of 6 years". Comment: No indication from which patient group the patients were not reviewed belonged, however information provided about why the patients could not be reviewed (moved/died/refused to participate). High rate of follow‐up. |
| Selective reporting (reporting bias) | Unclear risk | Comment: We identified a protocol (http://www.controlled‐trials.com/isrctn/pf/22417311) but it did not provide information on assessed outcomes. |